Monoclonal Antibody Production

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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Frequently Asked Questions for Monoclonal Antibody Production

Q: How does WuXi Biologics’ Protein Sciences Department accomplish a daily throughput of 1,000 molecules for monoclonal antibody production?

A: The Ultra 96+ platform was developed to meet customers’ needs for ultra-HTP monoclonal antibody production. The Ultra 96+ automates the transfection, expression, and purification on one integrated platform, and all steps are performed by a fully automated mechanical arm within a dedicated facility. To view how we accomplish the production of ~1,000 antibodies per day, watch the following video.

Q: What purification methods do you use for your mAb production service?

A: For the Ultra 96+ service, we use automated one-step magnetic beads purification. For the 777 service, we use automated two-step purification using affinity columns and SEC FPLC.

Q: What type of monoclonal antibodies are best suited for the Ultra 96+ and 777 services?

A: For the Ultra 96+ and 777 platforms, vanilla antibodies (e.g., hIgG1, hIgG4, mIgG1, mIgG2a) are most suitable. For other types of mAbs, please contact us and our specialists can discuss your molecule’s designs and provide more detailed service information.

Q: What’s the typical yield of your monoclonal antibody production?

A: The typical yield depends on the specific platform, but one of the strengths of our monoclonal antibody production capabilities is our high-titer expression system. For our Ultra 96+ service, the typical yield is 100 μg to 1.5 mg antibodies with the culture volume of 1 mL to 3 mL in either 96 or 24 deep-well plates. For our 777 service, the typical yield is 1.5 mg to 1 g with the culture volume of 20 mL to 1 L. If larger scales of antibody production are needed, we can scale up seamlessly using our WuXian Transient™ or WuXian Express™ platforms as the same high-titer production parental cell line is used for these productions.

Q: Can other QC methods be added to your Ultra 96+ service, such as SEC-HPLC?

A: Yes. Our Ultra 96+ platform covers A280, Caliper, and SEC-HPLC. Upon request, we can perform customized QC testing for a fee, but this will depend on the yield of your protein.

Q: Are antibodies produced by your Ultra 96+ platform appropriate for early developability tests?

A: Proteins produced by our Ultra 96+ platform, which utilizes one-step purification, are appropriate for most in vitro assays. However, for some cell-based assays in which protein purity and endotoxin levels may impact experimental outcomes, we recommend choosing our 777 platform that uses two-step purification to ensure that the proteins have high purity and very low endotoxin levels.

Q: What is the titer/yield difference between 96 and 24 well plates?

A: The titers between 96 and 24 well plates are similar. For a typical mAb, the Ultra 96+ platform can reach an average titer of ~0.6 g/L. With 24 well plates, we can usually expect ~1 g/L. If you want to know a true titer for your molecule that can be used as a reference for larger scale, it’s better to start with 20 mL, because that’s a true representation of the titer without the impact brought by the low volume.

Q: What types of protein tags can be used with your Ultra 96+ platform?

A: Our Ultra 96+ platform mostly accommodates monoclonal antibodies, which have Fc portion or fusion proteins. For fusion proteins, we usually recommend a His tag or Fc tag. However, we can also explore other options, such as Flag tag, upon request.

Q: For your 777 platform, can antibodies in a “non-IgG” format be made like bispecific antibodies? This would require co-transfection of three plasmids using knob-into-hole mutations.

A: Our 777 platform is most suitable for monoclonal antibodies and fusion proteins. For fusion proteins, strong expression levels are required to start with 20 mL culture. With our Quick ‘n’ Clean and Premium Bispecific Antibody platform, we can accommodate the knob-into-hole (KiH) design and our specialists can discuss your molecule’s designs and plan an automated 3-step purification for bispecific antibodies with high purity. Finally, we do perform co-transfection of different plasmids for your bsAb.

Q: Can you add buffer exchange to your Ultra 96+ service?

A: Typically, molecules come out of our Ultra 96+ service with the default platform buffer. However, we can perform a buffer exchange step for a small fee. Buffer change is included in larger-scale productions.

Q: Is the Ultra 96+ platform suitable for antibody production only, or for producing other proteins, too?

A: We can accommodate proteins with Fc or His tag with our Ultra 96+ platform. However, keep in mind that Fc fusion proteins may have variable expression levels. But the proteins must be expressed at a reasonable level to be accommodated with the Ultra 96+ platform. An example of such proteins is His-VHH, which has consistently high expression levels and can be produced with the Ultra 96+ platform.

Q: For your Ultra 96+ platform, how stable are proteins in PBS, and how do you avoid aggregation?

A: We generally don’t recommend proteins in PBS as its pH could change significantly during freeze-thaw cycle and impact protein stabilities. We usually recommend our platform buffer with a slightly lower pH. If you have a preferred buffer, we can accommodate it.

Q: Instead of purified antibodies, can you deliver conditional media with titer measurements?

A: Yes, we can accommodate that. In fact, some of our clients only need the supernatant for downstream binding assays, which we are happy to accommodate.

Q: Can you use your platform for membrane proteins and multimeric complexes?

A: In order to use our 777 platform, the protein must have strong expression levels. We start with 20 mL culture and can advance to one liter in the high-throughput fashion. However, in difficult-to-express proteins, we may need to conduct a 20 mL expression evaluation to understand the expression levels and properties of your molecule before scaling-up.

Q: Are all the steps in the 777 platform automated?

A: The 777 platform is an automated system, so all of the steps in the 777 are automated. The only step that isn’t automated is the cell culture step in which the cells are manually transferred to the incubator.

Q: What is the 777 platform’s throughput?

A: With our 777 platform, we can perform 96 transfections at 20 mL level in 1.5 hours. Our weekly capacity is 500 molecules.

Q: Is your 777 service suitable for non-vanilla antibody production?

A: Yes. This service is suitable for non-vanilla antibody production. It does depend on the expression level of the proteins, which must express at a reasonable level, such as >200 mg/L.

Q: What is your experience with the expression and purification of miniproteins? Can miniproteins production use your high-throughput platforms?

A: We have many successful cases working with miniproteins using our Ultra 96+ and 777 platforms. The yield and purity are at a superior level. If you are interested in producing miniproteins, please see our MiniProtein Line service for detailed service features and case studies.

Q: Do you also have insect cells, mammalian, and E. Coli expression systems?

A: Yes. We offer protein production services using mammalian, insect, and E. coli expression platforms.

More FAQs

Service Item	Deliverables	Duration	QC	Request A Quote
Gene synthesis, cloning and plasmid prep all included.
96 x 0.8 mL CHO/HEK293	100-800 μg	3 weeks	Titer, A280, Caliper (R/NR), and SEC-HPLC	Request A Quote
24 x 3 mL CHO/HEK293	0.5-2 mg	3 weeks	Titer, A280, Caliper (R/NR), and SEC-HPLC	Request A Quote

Service Item	Deliverables	Duration	QC	Request A Quote
Gene synthesis, cloning and plasmid prep all included.
20 mL CHO/HEK293	3-10 mg, average 4.5 mg after 2-step purification	3 weeks	A280, Caliper (R/NR) or SDS-PAGE (R/NR), SEC-HPLC, and endotoxin (<0.5 EU/mg)	Request A Quote
500 mL CHO/HEK293	100-500 mg	3 weeks		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

Large Scale mAb Production (Week)
Week 1	Week 2	Week 3	Week 4	Request A Quote
DNA Synthesis and Prep	WuXian Transient™ Expression	Purification and Analysis

Our Monoclonal Antibody Production Services

Key Features of Ultra 96+ Service:

Key Features of 777 Service:

Key Features of GramExpress Service:

Frequently Asked Questions for Monoclonal Antibody Production

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