Miniprotein 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 MiniProtein Line Service

Q: Is it possible to purify miniproteins without using a His-tag?

A: Absolutely. Besides His-tag, we also offer Flag-tag for miniproteins. But if your project is aiming for miniproteins with specific constructs, we can purify them without any tags, and then use conventional chromatography for purification.

Q: How do you check the purity of miniproteins?

A: We run SEC-HPLC to determine the purity of miniproteins. This technique separates the miniproteins based on their size, allowing us to pinpoint their relative abundance.

Q: How do you ensure the miniproteins are stable?

A: We’ve got various analytical methods to measure the stability of miniproteins. For instance, we can measure their melting temperature (TM) or examine their structure with circular dichroism (CD).

Q: Have you scaled miniprotein production beyond 1-liter scale?

A: Our Protein Sciences (PS) Department at WuXi Biologics focuses on the research domain, with our expertise primarily rooted in smaller-scale projects. However, when scaling up to 1 L using our CHO transient platform, we can achieve yields of 400-500 mg of protein. We are capable of scaling up further without an upper limit.

Q: Can you offer computational services to enhance protein properties, such as solubility?

A: We do not offer computational services for miniprotein property improvement. The field of miniproteins is rapidly advancing, and we lean on our client’s expertise to guide protein development.

Q: What types of downstream assays do you provide for miniproteins?

A: After producing miniproteins, our go-to downstream assays include BLI, SPR, and occasionally ELISA for certain cases. These methods, especially BLI, are highly efficient for HTP screening of miniproteins within a short timeframe. Additionally, we can conduct sophisticated, low-throughput assays for your specialized proteins.

Q: What are the typical yields you've observed for miniproteins, and how do you determine a 'normal' range for well-expressed ones?

A: We consider expression level >100 mg/L to be typical for most miniproteins. In a case study where we expressed 48 miniproteins in CHO cells, the average yield was 197 mg/L.

Q: How does sequence homology with different species like E. coli, mammals, and insects affect the expression of de novo synthesized miniproteins?

A: Our understanding of sequence homology across various species and its impact on miniprotein expression is limited, since these proteins are designed de novo. Generally, we observe higher expression levels in CHO compared to E. coli, regardless of sequence homology. Other factors such as the maturity of the design algorithm and the structural characteristics of the miniproteins also influence expression levels.

Q: What considerations are important for improving the yield of de novo designed miniproteins?

A: The miniproteins’ structures are crucial for their yields. Miniproteins with stable hydrophobic cores with proper folding are more likely to be expressed successfully in both E. coli and CHO. For miniproteins designed to function intracellularly with free cysteines, E. coli is often preferred. Conversely, miniproteins lacking free cysteines or those with disulfide bonds are better expressed in CHO. Additionally, when miniproteins serve as building blocks for mAbs or bsAbs, CHO is recommended to achieve optimal expression levels.

Q: Can miniproteins that are insoluble in E. coli achieve soluble expression in CHO cells?

A: Yes, we have encountered cases where miniproteins that are insoluble in E. coli were successfully expressed in a soluble form in CHO cells.

Q: What are the minimum and maximum lengths of miniproteins that you can produce, and do you offer services for sequence design?

A: Our expression system produces miniproteins with lengths between 80 and 200 amino acids. The constraint on the maximum size is primarily related to the capabilities of algorithmic design rather than our expression system. Currently, we do not provide services for sequence design.

Q: How does the pI range influence the selection of miniprotein sequences, and does it affect expression or purification efficiency?

A: While the pI range of miniproteins typically does not pose issues, miniproteins with a high concentration of basic amino acids can lead to proteolysis in both E. coli and CHO cells. Monitoring the proteolysis profile of these miniproteins is essential for in vivo therapeutic applications to ensure their stability and effectiveness. To support this, we offer serum stability tests as part of our micro developability services.

Q: Do you offer assays to evaluate the immunogenicity of miniproteins?

A: Yes, we offer both in silico immunogenicity prediction to identify sequences with potential immunogenicity issues and ex vivo immunogenicity assays to assess the immunogenicity risk of miniproteins.

More FAQs

Service Item	Deliverables	Duration	QC	Request A Quote
24 x 3 mL CHO	0.5 mg, single-step affinity purification	3-4 weeks	Bradford, SEC-HPLC, SDS-PAGE LC-MS (optional)	Request A Quote
≥20 mL CHO	2 mg from 20 mL, two-step purification	3-4 weeks	SEC-HPLC, SDS-PAGE, endotoxin (<0.5 EU/mg) LC-MS (optional)	Request A Quote

Key Features of MiniProtein Line

Frequently Asked Questions for MiniProtein Line Service

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