Antibody Production Services | 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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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).

Learn more

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.

Learn more

Quality Control

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

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.

Learn more

Key Features:

High-Titer Expression: Harnessing the latest advancements in biotechnology, we excel in achieving high titer expression of antibodies, maximizing the yield for your antibodies.

Premium Quality: Our team of experts are comprised of skilled scientists who are well-versed in both expression and purification of antibodies. With our rigorous quality control measures throughout the antibody production process, we ensure consistent and reliable results.

Speedy Turnaround: Time is of the essence in research. With our high titer expression platform and optimized operation processes, we can deliver your antibodies in just 3 weeks.

Cost-effective Solutions: Empowered by our high titer expression platform, we achieve the same amount of antibodies with a much smaller culture volume and a shorter production time, which translates to the low cost to our customers.

Extensive Experience in the Production of Diverse Antibodies

From traditional monoclonal antibodies to innovative bispecific antibodies and various antibody fragments such as Fab fragments, VHH, and scFv, we synergize our drug-making knowledge with antibody production to deliver unparalleled results, ensuring that our clients receive top-tiered antibodies to drive groundbreaking research and therapeutic advancements.

Frequently Asked Questions for Antibody Production

Q: Which cell lines are used by WuXi Biologics for antibody production?

A: We primarily use CHO cells for antibody production. We have made significant investments in optimizing our cell engineering and cell growth processes to achieve high titer expression of antibodies in the CHO cells, enhancing the antibody production efficiency.

Q: How long does it typically take to produce antibodies with WuXi Biologics?

A: The antibody production timeline varies depending on several factors, including the type of antibody, the scale of production, and specific client requirements. Using our HTP platforms and high titer expression CHO cells, the timeline could be as fast as 2 weeks, with a daily throughput of 1,000+ molecules.

Q: What makes WuXi Biologics’ antibody production unique?

A: Our unique advantage lies in providing valuable insights and guidance to customers throughout the entire antibody drug development process, enabling them to navigate around common pitfalls and overcome challenges effectively. This comprehensive end-to-end viewpoint and approach ensures a seamless and speedy journey from concept to market, making us a trusted and reliable partner for customers in need of antibody production services.

Q: How do I choose the right expression system (CHO, HEK293 or NS0) for my project?

A: For projects involving new molecules, CHO cells are your ideal choice because of our well-established ultra-high-titer CHO expression platform. For projects encountering issues like truncation issues, HEK293 cells are recommended. In cases where your molecules have severe aggregation issues caused by disulfide bonds in CHO or HEK293, NS0 cells can be considered as a last option.

Q: What makes a good host for producing therapeutic antibodies?

A: An optimal host expresses target antibodies with high titers, optimal glycosylation modifications, low levels of N-linked mannose-5 glycan and afucosylation, and minimal truncations. Additionally, the host should demonstrate efficient transfection, low lactate level, and rapid doubling time.

Q: Are there risks in switching my therapeutic antibody production from HEK293 to CHO?

A: These potential risks include titer variations and different glycosylation and other PTMs, sometimes truncations. The difference may lead to inconsistent efficacy, PK, challenging CMC and late-stage developments. For molecules with therapeutic purposes, it’s highly desirable to use the same CHO host from early discovery to commercial manufacturing.

Q: Why do we need ADCC?

A: Antibody-dependent cellular cytotoxicity (ADCC) is one of the most important effector mechanisms of tumor-targeting antibodies. The need for ADCC depends on the specific therapeutic strategy and mechanism of action (MOA) of your molecule. You may leverage our CHO-Fut8 technology to enhance ADCC effects. On the other hand, sometimes ADCC effects must be eliminated, such as T-cell engagers. Antibodies can be engineered to reduce or increase the ADCC effect. Consult our specialists for unique requirements of your project.

Q: Should I consider afucosylation for my antibodies?

A: Afucosylation involves the reduction or removal of fucose in the Fc region of an antibody. This modification can significantly boost the antibody’s affinity for FcγRIIIa on natural killer (NK) cells, which in turn enhances ADCC. Careful MOA studies must be carried out to make the decision. You need to find a balance between efficacy and toxicity.

Q: How does WuXi Biologics’ drug development expertise contribute to antibody production?

A: We have cultivated a rich pipeline comprising various drug modalities, including regular mAb, ADC, bsAb and fusion proteins. Leveraging our extensive experience, we can assist clients during the early research stage and accumulate valuable insights into the developability of different modalities. While we primarily focus on research-grade antibodies, WuXi Biologics’ extensive drug development expertise allows us to guide clients through a smooth transition from research to CMC.

More FAQs

Our Antibody Production Services

Key Features:

Antibody Production Services (by Antibody Type)

Monoclonal Antibody Production

Bispecific Antibody Production

Fab Fragments, VHH, scFv

Extensive Experience in the Production of Diverse Antibodies

Our Featured Antibody Production Services

Frequently Asked Questions for Antibody Production

Related Content

Your Project. Our Expertise.