$Our expertise spans discovery, development, and cGMP manufacture of biologics from mammalian cell culture. Leveraging 6 discovery platforms, a top-tier CMC development team, and an extensive supply chain, we deliver seamless programs for all your biologics drug development needs.
$Comprehensive CMC development and cGMP manufacturing microbial fermentation platform. E. coli and yeast-based expression systems for the production of plasmid DNA and recombinant proteins.
$A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
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$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
Mammalian-Derived Product Services
A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
Monoclonal Antibodies
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Bispecific & Multispecific Antibodies
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Fc-Fusion Proteins
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Antibody Fragments
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Recombinant Proteins / Enzymes / Cytokines
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Non-Vaccine Viral Products
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Antibody Drug Conjugates (ADCs)
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Virus-Like Particles (VLPs)
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$High quality, expert services for biologics produced from microbial fermentation.
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
$Discover information about the various drug development services we provide for this product type
Microbial-Derived Product Services
High quality, expert services for biologics produced from microbial fermentation.
Antibody Fragments
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Enzymes
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Cytokines
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Plasmid DNA (pDNA)
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Virus-Like Particles (VLPs)
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RNA / mRNA
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$Integrated Discovery Platform From Concept to IND
$Utilizing one of the world’s largest and most experienced development teams, we have the resources, technologies and expertise to drive your program toward IND and BLA in the most efficient and cost-effective manner.
$Multiple state-of-the-art, premier quality cGMP clinical- and commercial-scale drug substance (DS) and drug product (DP) facilities across four countries for the production of a wide array of biologics from both mammalian and microbial expression systems.
$We provide extensive expertise for in-process, characterization, release and stability method development and testing either in support of our integrated biologics development platforms or as standalone projects. Our wide-range of analytical and biosafety testing Centers of Excellence and regulatory agency-approved quality control (QC) laboratories are the backbone of every service we provide our clients.
$Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
$Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
Integrated Discovery Service
Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
Protein Sciences
Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
$We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
$Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
$Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
$Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
$We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
$We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
$Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
$Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
$Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
Protein Sciences
We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
Cell Line Engineering
Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
Analytical Sciences
Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
Process Development & Scale Up
Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
Late-Stage Development and Process Characterization
We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
Formulation & Drug Product Development
We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
Cell Banking & Characterization
Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
Viral Clearance
Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
Regulatory Support
Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
$Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
$Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
$We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
$Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
Clinical DS GMP Manufacturing
Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
Clinical DP GMP Manufacturing
Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
Commercial DS GMP Manufacturing
We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
Commercial DP GMP Manufacturing
Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
$High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
$We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
$Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Biosafety Testing
High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
Analytical Testing
We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
Centers of Excellence (CoE)
Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
Global Quality Control (QC)
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
$We provide world-class quality systems, harmonized across our global manufacturing sites and approved by multiple global regulatory agencies, including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANVISA and Health Canada for the production and testing of a wide array of biologics.
$Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
$Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
$Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
Global Compliance
Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
Quality Assurance
Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
Quality Control
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Regulatory Affairs
Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
$Comprehensive, high-quality, end-to-end solutions driving efficiency, decreasing time to clinic and reducing project risks from concept to commercialization.
$A full spectrum of discovery services and technologies for the engineering, generation, characterization, optimization and selection of high-potency novel antibody therapeutics.
$Cutting-edge bioprocessing platforms and technologies designed to enable high-quality biologics to enter clinical trials faster, more efficiently and more cost-effectively.
$Advanced biomanufacturing platforms empower our global healthcare partners to deliver biologics to the clinic and on to the market for the benefit of patients worldwide.
$One-stop solution for superior animal health outcomes.
$Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
$Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
$Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
Target to Lead
Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
DNA to IND
Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
IND to BLA
Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
$The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
$Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
$Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.
$Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
$An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
$An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
Bispecific & Multispecific Antibodies - WuXiBody™
The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
Advanced Hybridoma Platform - WuXiHybrid™
Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
Naive Phage Display Library - WuXiLiAb™
Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.
VHH-based Multispecific Antibody Platform - SDARBody™
Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
ScFv-based BsAb & MsAb Antibody Platform - SKYBody™
An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
VAST-B Single B-Cell Antibody Discovery Platform
An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
$Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
$Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
$Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
$This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
$Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
$Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
Ultra-Intensified Fed-batch platform - WuXiUI™
Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
Rapid Research Material Generation - WuXian™
Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
Cell Line Development - WuXia™
Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
Continuous Bioprocessing - WuXiUP™
This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
ADC Development Platform - WuXiDAR4™
Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
High Concentration & HTP DP Platform - WuXiHigh™
Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
$We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
$Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
$Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
$Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
Single-Use Bioreactors
We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
Scale-Out Biomanufacturing
Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
Robotic Aseptic Filling
Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
Continuous Manufacturing Process
Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
Animal Health Technologies
We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.
WuXi Biologics
Offering End-to-End Solutions
$Our expertise spans discovery, development, and cGMP manufacture of biologics from mammalian cell culture. Leveraging 6 discovery platforms, a top-tier CMC development team, and an extensive supply chain, we deliver seamless programs for all your biologics drug development needs.
$A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
Mammalian-Derived Product Services
A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
$Discover information about the various drug development services we provide for this product type
Monoclonal Antibodies
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$Discover information about the various drug development services we provide for this product type
Bispecific & Multispecific Antibodies
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$Discover information about the various drug development services we provide for this product type
Fc-Fusion Proteins
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$Discover information about the various drug development services we provide for this product type
Antibody Fragments
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$Discover information about the various drug development services we provide for this product type
Recombinant Proteins / Enzymes / Cytokines
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$Discover information about the various drug development services we provide for this product type
Non-Vaccine Viral Products
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$Discover information about the various drug development services we provide for this product type
Antibody Drug Conjugates (ADCs)
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$Discover information about the various drug development services we provide for this product type
Virus-Like Particles (VLPs)
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$Comprehensive CMC development and cGMP manufacturing microbial fermentation platform. E. coli and yeast-based expression systems for the production of plasmid DNA and recombinant proteins.
$High quality, expert services for biologics produced from microbial fermentation.
Microbial-Derived Product Services
High quality, expert services for biologics produced from microbial fermentation.
$Discover information about the various drug development services we provide for this product type
Antibody Fragments
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$Discover information about the various drug development services we provide for this product type
Enzymes
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$Discover information about the various drug development services we provide for this product type
Cytokines
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$Discover information about the various drug development services we provide for this product type
Plasmid DNA (pDNA)
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$Discover information about the various drug development services we provide for this product type
Virus-Like Particles (VLPs)
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$Discover information about the various drug development services we provide for this product type
RNA / mRNA
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$Integrated Discovery Platform From Concept to IND
$Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
Integrated Discovery Service
Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
$Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
Protein Sciences
Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
$Utilizing one of the world’s largest and most experienced development teams, we have the resources, technologies and expertise to drive your program toward IND and BLA in the most efficient and cost-effective manner.
$We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
Protein Sciences
We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
$Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
Cell Line Engineering
Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
$Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
Analytical Sciences
Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
$Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
Process Development & Scale Up
Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
$We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
Late-Stage Development and Process Characterization
We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
$We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
Formulation & Drug Product Development
We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
$Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
Cell Banking & Characterization
Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
$Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
Viral Clearance
Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
$Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
Regulatory Support
Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
$Multiple state-of-the-art, premier quality cGMP clinical- and commercial-scale drug substance (DS) and drug product (DP) facilities across four countries for the production of a wide array of biologics from both mammalian and microbial expression systems.
$Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
Clinical DS GMP Manufacturing
Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
$Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
Clinical DP GMP Manufacturing
Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
$We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
Commercial DS GMP Manufacturing
We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
$Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
Commercial DP GMP Manufacturing
Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
$We provide extensive expertise for in-process, characterization, release and stability method development and testing either in support of our integrated biologics development platforms or as standalone projects. Our wide-range of analytical and biosafety testing Centers of Excellence and regulatory agency-approved quality control (QC) laboratories are the backbone of every service we provide our clients.
$High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
Biosafety Testing
High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
$We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
Analytical Testing
We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
$Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
Centers of Excellence (CoE)
Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Global Quality Control (QC)
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
$We provide world-class quality systems, harmonized across our global manufacturing sites and approved by multiple global regulatory agencies, including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANVISA and Health Canada for the production and testing of a wide array of biologics.
$Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
Global Compliance
Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
$Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
Quality Assurance
Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Quality Control
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
$Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
Regulatory Affairs
Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
$Comprehensive, high-quality, end-to-end solutions driving efficiency, decreasing time to clinic and reducing project risks from concept to commercialization.
$Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
Target to Lead
Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
$Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
DNA to IND
Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
$Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
IND to BLA
Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
$A full spectrum of discovery services and technologies for the engineering, generation, characterization, optimization and selection of high-potency novel antibody therapeutics.
$The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
Bispecific & Multispecific Antibodies - WuXiBody™
The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
$Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
Advanced Hybridoma Platform - WuXiHybrid™
Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
$Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.
Naive Phage Display Library - WuXiLiAb™
Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.
$Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
VHH-based Multispecific Antibody Platform - SDARBody™
Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
$An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
ScFv-based BsAb & MsAb Antibody Platform - SKYBody™
An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
$An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
VAST-B Single B-Cell Antibody Discovery Platform
An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
$Cutting-edge bioprocessing platforms and technologies designed to enable high-quality biologics to enter clinical trials faster, more efficiently and more cost-effectively.
$Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
Ultra-Intensified Fed-batch platform - WuXiUI™
Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
$Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
Rapid Research Material Generation - WuXian™
Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
$Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
Cell Line Development - WuXia™
Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
$This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
Continuous Bioprocessing - WuXiUP™
This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
$Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
ADC Development Platform - WuXiDAR4™
Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
$Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
High Concentration & HTP DP Platform - WuXiHigh™
Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
$Advanced biomanufacturing platforms empower our global healthcare partners to deliver biologics to the clinic and on to the market for the benefit of patients worldwide.
$We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
Single-Use Bioreactors
We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
$Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
Scale-Out Biomanufacturing
Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
$Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
Robotic Aseptic Filling
Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
$Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
Continuous Manufacturing Process
Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
$One-stop solution for superior animal health outcomes.
$We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.
Animal Health Technologies
We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.
$Our expertise spans discovery, development, and cGMP manufacture of biologics from mammalian cell culture. Leveraging 6 discovery platforms, a top-tier CMC development team, and an extensive supply chain, we deliver seamless programs for all your biologics drug development needs.
$A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
Mammalian-Derived Product Services
A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
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Monoclonal Antibodies
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Bispecific & Multispecific Antibodies
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Fc-Fusion Proteins
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Antibody Fragments
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Recombinant Proteins / Enzymes / Cytokines
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Non-Vaccine Viral Products
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Antibody Drug Conjugates (ADCs)
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Virus-Like Particles (VLPs)
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$Comprehensive CMC development and cGMP manufacturing microbial fermentation platform. E. coli and yeast-based expression systems for the production of plasmid DNA and recombinant proteins.
$High quality, expert services for biologics produced from microbial fermentation.
Microbial-Derived Product Services
High quality, expert services for biologics produced from microbial fermentation.
$Discover information about the various drug development services we provide for this product type
Antibody Fragments
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Enzymes
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Cytokines
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Plasmid DNA (pDNA)
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$Discover information about the various drug development services we provide for this product type
Virus-Like Particles (VLPs)
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RNA / mRNA
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$Integrated Discovery Platform From Concept to IND
$Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
Integrated Discovery Service
Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
$Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
Protein Sciences
Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
$Utilizing one of the world’s largest and most experienced development teams, we have the resources, technologies and expertise to drive your program toward IND and BLA in the most efficient and cost-effective manner.
$We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
Protein Sciences
We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
$Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
Cell Line Engineering
Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
$Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
Analytical Sciences
Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
$Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
Process Development & Scale Up
Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
$We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
Late-Stage Development and Process Characterization
We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
$We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
Formulation & Drug Product Development
We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
$Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
Cell Banking & Characterization
Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
$Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
Viral Clearance
Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
$Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
Regulatory Support
Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
$Multiple state-of-the-art, premier quality cGMP clinical- and commercial-scale drug substance (DS) and drug product (DP) facilities across four countries for the production of a wide array of biologics from both mammalian and microbial expression systems.
$Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
Clinical DS GMP Manufacturing
Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
$Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
Clinical DP GMP Manufacturing
Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
$We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
Commercial DS GMP Manufacturing
We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
$Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
Commercial DP GMP Manufacturing
Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
$We provide extensive expertise for in-process, characterization, release and stability method development and testing either in support of our integrated biologics development platforms or as standalone projects. Our wide-range of analytical and biosafety testing Centers of Excellence and regulatory agency-approved quality control (QC) laboratories are the backbone of every service we provide our clients.
$High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
Biosafety Testing
High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
$We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
Analytical Testing
We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
$Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
Centers of Excellence (CoE)
Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Global Quality Control (QC)
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
$We provide world-class quality systems, harmonized across our global manufacturing sites and approved by multiple global regulatory agencies, including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANVISA and Health Canada for the production and testing of a wide array of biologics.
$Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
Global Compliance
Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
$Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
Quality Assurance
Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Quality Control
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
$Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
Regulatory Affairs
Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
$Comprehensive, high-quality, end-to-end solutions driving efficiency, decreasing time to clinic and reducing project risks from concept to commercialization.
$Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
Target to Lead
Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
$Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
DNA to IND
Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
$Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
IND to BLA
Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
$A full spectrum of discovery services and technologies for the engineering, generation, characterization, optimization and selection of high-potency novel antibody therapeutics.
$The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
Bispecific & Multispecific Antibodies - WuXiBody™
The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
$Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
Advanced Hybridoma Platform - WuXiHybrid™
Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
$Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.
Naive Phage Display Library - WuXiLiAb™
Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.
$Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
VHH-based Multispecific Antibody Platform - SDARBody™
Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
$An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
ScFv-based BsAb & MsAb Antibody Platform - SKYBody™
An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
$An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
VAST-B Single B-Cell Antibody Discovery Platform
An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
$Cutting-edge bioprocessing platforms and technologies designed to enable high-quality biologics to enter clinical trials faster, more efficiently and more cost-effectively.
$Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
Ultra-Intensified Fed-batch platform - WuXiUI™
Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
$Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
Rapid Research Material Generation - WuXian™
Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
$Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
Cell Line Development - WuXia™
Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
$This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
Continuous Bioprocessing - WuXiUP™
This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
$Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
ADC Development Platform - WuXiDAR4™
Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
$Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
High Concentration & HTP DP Platform - WuXiHigh™
Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
$Advanced biomanufacturing platforms empower our global healthcare partners to deliver biologics to the clinic and on to the market for the benefit of patients worldwide.
$We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
Single-Use Bioreactors
We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
$Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
Scale-Out Biomanufacturing
Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
$Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
Robotic Aseptic Filling
Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
$Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
Continuous Manufacturing Process
Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
$One-stop solution for superior animal health outcomes.
$We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.
Animal Health Technologies
We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.
In this podcast, we interviewed Dr. J.J. Luo, Executive Director and Dr. Lily Yin, Head of Biologics Conjugation Development, at WuXi Biologics about the state of the ADC marketplace and the challenges in developing antibody drug conjugates. We then dove into reasons behind why they built a dedicated manufacturing facility for ADCs and other bioconjugates and how a single-source development platform can benefit bioconjugate drug development efforts.
Podcast Notes:
I began the podcast by asking Dr. Luo about WuXi Biologics’ investment in and construction of multiple clinical and commercial scale facilities around the world. I pointed out that nearly all of these facilities are dedicated to the GMP production of Drug Substance and Drug Product of antibody or recombinant protein therapeutics, but their new facility appears to be dedicated for a very specific niche within the biologics industry. JJ explained that the new facility was purpose-built for the manufacture of a wide range of bioconjugates, in which the largest class of these products would be Antibody Drug Conjugates. He went on to say that this new facility is part of WuXi Biologics’ new state-of-the-art integrated Biologics Conjugation Solution Center in Wuxi City, China. The center will consolidate all bioconjugate drug development and commercial manufacturing of bioconjugates in the future.
I followed up by asking JJ about the drivers behind building a facility dedicated solely to ADCs and other bioconjugates. He stated that although bioconjugates are a subset of the greater biological therapeutic marketplace, various market research reports have shown a year on year increase in the number of ADCs and other bioconjugates entering clinical trials over the past 5 years by roughly 12% per year worldwide. Some estimate that commercial sales of ADCs will grow 22% annually for the next 5 to 10 years. In addition, based on drug company pipeline data, it appears that this trend will continue into the foreseeable future. JJ made it clear that WuXi Biologics’ mission is to provide open access drug development platforms to ensure that every drug can be made and every disease can be treated. Given WuXi Biologics’ expertise, vast capabilities, and resources they believe that they can provide a single-source product development and supply chain for companies developing these novel therapeutics.
Dr. Yin added that WuXi Biologics has a strong history of providing extensive product development and manufacturing services to clients. They have developed a wide variety of bioconjugates from idea to GMP manufacturing for clinical study. She goes on to share that they have provided full CMC services for 11 IND filings for bioconjugate products in just the last few years and 25% of the total IND filings for ADCs in 2018. With the new bioconjugation facility, WuXi Biologics’ has increased GMP manufacturing capacity for both drug substance and drug product and can meet their client’s needs for clinical supply while still offering additional capacity for new clients.
Next, I asked Dr. Yin about their ability to provide a single-source for all bioconjugate needs. I clarified that ADCs and other bioconjugates are complex molecules with both chemical and biological components. I wanted to know how they would be able to provide all the services required to get from early discovery to clinical supply and if there were any gaps. Lily said that WuXi Biologics is known for their ability to take clients from early discovery and lead generation of antibody therapeutics into development and the clinic. Through WuXi Biologics’ expertise and single-source services they are able to provide this without having to use another service vendor. Lily encouraged listeners to go to their website to learn more about their comprehensive capabilities. https://www.wuxibiologics.com/services-solutions/antibody-drug-conjugates.
Then we discussed how some of the new bioconjugate modalities often contain highly potent or highly toxic payloads thus requiring development and manufacture of these intermediates and the subsequent conjugation to be done in special facilities equipped to handle these compounds. They often also require additional oversight from regulatory authorities. I asked JJ how WuXi Biologics is addressing these types of intermediates and compounds. JJ described how their new facility has been purpose-built to handle highly potent and toxic materials. The design and construction were set to meet U.S. FDA, EMA and China National Medical Products Administration (NMPA) standards for those compounds.
We then focused on how ADCs have historically had many challenges in development and also challenges in demonstrating efficacy in humans. I asked Lily what is the industry doing to help mitigate these development challenges, reduce risks, and help ensure success to move more of these treatments into the clinic and hopefully to commercialization. Lily acknowledged that there have been set-backs and challenges in the field, but stated that bioconjugates are still a relatively young field with a lot left to learn on how we can more effectively develop successful drugs. She went on to say that the good news is that there are 5 ADCs on the market with approximately another 10 in late stage clinical trials with over half of those having obtained “Fast-track” status. WuXi Biologics believes that this demonstrates that the industry is beginning to turn the corner with better understanding of how to develop these molecules for clinical success. She shared that there is a better understanding of how to engineer antibodies to find suitable targets, how to select an active toxin, and how to use better linker chemistry to create better targeted binding characteristics, improved in vivo half-life, more consistently controlled drug-to-antibody ratio, residual free drug levels and better payload release to control drug levels in vivo.
I then asked Lily what specifically WuXi Biologics is doing to help further the ADC field. She said that they have now worked with so many different antibody or other biological molecules, linker and payload chemistries and combinations thereof, that they are uniquely qualified to advise clients on development strategies that will best suit their needs and ensure success. They have strong manufacturability and developability strategies when evaluating the various technologies and bioconjugation options to provide sound data driven decisions for lead selection and throughout development in order to generate a robust GMP process. Looking at many of the challenges and pitfalls of certain linker and bioconjugation schemes WuXi Biologics has continually developed their own new technology platforms for linkers and in some cases proprietary modifications to enhance certain payloads to increase their effectiveness for first in human trials.
I followed up by asking Lily to elaborate on the proprietary technologies she mentioned and also to discuss the benefits of WuXi Biologics’ IP. Lily said that they have developed a novel linker for Lysine-based conjugation that demonstrates higher reactivity, better solubility and a more flexible range of conjugation temperatures and the ability to conjugate this linker to other molecules beyond IgGs. Their unique payload chemistry involves more homogenous drug loading for cysteine conjugation. She went on to say that they would be happy to discuss more under a CDA with any company who is interested.
Next I asked JJ if these technologies were scale-able. He clarified that WuXi Biologics designed all of these technologies with an eye for ease of formulation and to be able to scale up for clinical trial scale and beyond.
I followed up with JJ and asked what manufacturing scales could be achieved at the new facility. He said that the new facility could produce up to 50 batches per year with up to 2 kilograms per batch for drug substance. He said that they can perform both liquid and lyophilization for Drug Product fills with a maximum of 100,000 2R vials per batch for liquid fills and 25,000 2R vials per batch for lyophilized fills. In addition, they are able to provide GMP lyophilization of ADCs in various vial sizes including 2R, 6R, 10R, 20R and 50R. He also mentioned that the facility could perform filling of other non-bioconjugate products such as small molecule or peptide therapeutics as long as they require liquid or lyo type fills. He added that since this is a multi-product and multi-use facility, they are utilizing single-use systems including single-use compounding vessels, tubing, bags, and filling needles for the entire bioconjugation and drug product compounding, filling and finishing process. They do this to greatly reduce risk during the GMP manufacturing runs and provide the highest level of quality assurance for their clients.
I asked that since they are working with highly potent and toxic compounds in this facility were there any special equipment requirements. JJ shared that isolator-based systems are widely utilized in the industry for working with highly potent or highly toxic materials, so they utilize isolator-based systems for payload and linker dispensing and dissolution, filling and lyophilization. In addition, fully automated equipment is used for vial washing and depyrogenation, filling, and for automated loading and unloading the drug product containers into and out of the lyophilizer. Filling is operated by an automated peristaltic pump dosing system and weight check is performed using on-line weighing system for automatic fill weight adjustment. If required, the filling line is also equipped with Nitrogen blanketing capabilities and light protected material handling is also available from start of fill processing to final package steps.
Lastly, I asked when they will start GMP ADC manufacturing activities. JJ said that they have just started operating the facility and their first GMP production will be in the third quarter of this year. There are nearly 20 lots that are scheduled including 10 GMP lots by the end of this year. So, although he said that they will be busy, there is still capacity for this year and next year as well.
I closed by thanking JJ and Lily for their time. The interview was very informative and provided good insight into the current state of the ADC/bioconjugate marketplace and how the industry and WuXi Biologics is working to overcome the historical challenges. It looks like a bright future for bioconjugated therapeutics is ahead of us.
