Protein Sciences

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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Quality Control

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Key Features of WuXian Transient™ Expression System

High-Titer expression levels: More than 1 g/L on Day 7.

Seamless scale-up: WuXian Transient™ and WuXian Express™ (CHO stable cell line system yielding 10-1,000 grams of antibodies) are both derived from the same parental CHO cells ensuring comparable product attributes and titer as you increase your production scale.

Short timelines: Gram-level material delivered within 4-5 weeks.

Key Features of the WuXian Express™ (CHO Stable Pool) Expression System

High productivity stable pool: Average >2.8 g/L for various proteins, and up to 6 g/L for hIgG1/4.

Titer consistency: Pool-to-pool titer variation <10%.

Seamless integration to CMC: The same cell lines used to achieve high comparability characteristics of the product and cell culture process.

Flexible scale: 20 mL to 100 L.

Frequently Asked Questions

Q: What are the typical yields for Fab, VHH, and scFv production?

A: Our WuXian Transient™ platforms consistently deliver high-titer expression for all antibody fragments:

Regular human Fab: 500 mg/L to 1 g/L
His-ScFv: 100 to 300 mg/L
His-VHH: ~500 mg/L
Fc-VHH: Comparable to regular IgG

For reference, most regular human IgGs produced in our CHO transient system yield approximately 1 to 1.5 g/L.

Q: Is it easier to produce human/rabbit/rat Fab?

A: Producing human Fab is relatively straightforward, with consistently higher yields. However, for other species such as rat or rabbit, yields may be lower, and purification can be more challenging due to limited resin options. In these cases, incorporating a His or Flag tag for purification is recommended.

Q: What are the advantages of developing antibody fragments over the full-length antibodies as therapeutics?

A: Antibody fragments offer several advantages, including improved tissue penetration due to their smaller size, increased engineering flexibility, and reduced immunogenicity. They also serve as versatile building blocks for bispecific antibodies, facilitating the development of innovative therapeutic modalities. However, antibody fragments generally have a shorter half-life, which may be beneficial for certain applications. If extending the half-life is important, incorporating an Fc region or using a bispecific antibody format could be considered.

Q: Why is deblocking important during the production of Fab’?

A: During Fab’ expression in CHO cells, adducts can form when cysteine or glutathione from the culture medium binds to the Fab’. Deblocking involves using a reducing reagent to remove these adducts, ensuring that the cysteine residues in the Fab’ are free and available for conjugation.

Q: For antibody fragment expression, which expression system is considered the best?

A: Compared to E. coli, our ultra-high titer CHO expression system offers superior yields and significantly reduced endotoxin levels, making it the preferred choice for producing antibody fragments. Additionally, CHO cells are critical for expressing bispecific antibodies, which are often built from antibody fragments.

Q: What purity percentage is acceptable for Fc-VHH after affinity purification?

A: A purity greater than 95% after affinity purification is considered excellent. However, the acceptable purity may vary depending on the quantity and properties of the target molecules, with a typical minimum threshold set at 50%. Other factors such as titers, resin recovery, and stability should also be considered. A comprehensive Micro Developability package is recommended to assess the candidate’s suitability for further development into CMC.

Q: Among Fab, VHH, and scFv, which antibody fragment has the most therapeutic applications?

A: Each fragment has unique characteristics that make it suitable for specific therapeutic applications. Leveraging our expertise, we can assist in refining your therapeutic molecules to enhance their quality and efficacy. Notably, our expertise in scFv molecular design allows us to address aggregation challenges and facilitate the conversion of regular IgGs into scFvs with improved developability.

Q: What makes the linker design important in the scFv case study, and what's the principle behind it?

A: If a linker is derived from a phage display campaign, it’s typically appropriate for the application. However, when converting a regular IgG into an scFv, the linker must be carefully designed to ensure proper spacing and flexibility between the VH and VL domains. This design is crucial to prevent aggregation and maintain the structural integrity of the scFv.

Service Item	Deliverables	Expression Scale	Duration	QC	Request A Quote
Highly customizable package with multi-step purification	Any antibody, tagged or untagged protein with need for scale up manufacturing	1-100 L	3-5 weeks	<0.5 EU/mg endotoxin control, QC incl. Titer, A280, Caliper (R/NR) or SDS-PAGE, SEC-HPLC	Request A Quote
Additional QC	RP-HPLC, bioburden, DSF, DSC, SPR, LC/MS, SEC-MALS, peptide mapping, glycan profiling, cIEF, CHO HCP, residual DNA, ELISA, Western blot, freeze thaw study, micro-developability testing

Service Item	Deliverables	Expression Scale	Duration	QC	Request A Quote
Gram-level protein generation for animal study and developability study in CHO cells	Any antibody, tagged or untagged protein with need for scale-up manufacturing	20 mL-100 L	6-7 weeks	A280, Caliper (R/NR) or SDS-PAGE (R/NR), SEC-HPLC, and endotoxin (<0.5 EU/mg)	Request A Quote
Additional QC	RP-HPLC, bioburden, DSF, DSC, SPR, LC/MS, SEC-MALS, peptide mapping, glycan profiling, cIEF, CHO HCP, residual DNA, ELISA, Western blot, freeze thaw study, micro-developability testing

Key Features of WuXian Transient™ Expression System

Key Features of the WuXian Express™ (CHO Stable Pool) Expression System

Frequently Asked Questions

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