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Protein Sciences

Uniting Drug Development Expertise with Antibody & Protein Production Services

Fab, VHH, ScFv Antibody Fragment Production

Supporting Your Antibody Fragments Production Needs

 

At WuXi Biologics, our Protein Sciences (PS) Department produces high-quality antibody fragments to accelerate your research and bring innovative solutions to the market. Our deep experience and optimized production processes ensure high-titer expression of Fab, VHH, scFv, and sdAb (nanobody) using our WuXian™ Transient, WuXian™ Express, and E. coli expression systems.

High-titer expression of premium-quality antibody fragments, including Fab, VHH, scFv, and sdAb (nanobody) using CHO and HEK 293.

WuXian™ Transient (CHO & HEK293) Expression System

 

Over 70% of biologics, and nearly all monoclonal antibodies (mAbs), are produced in Chinese hamster ovary (CHO) cells, as these cells can generate proteins with bioactive post-translational modifications (PTMs) akin to those produced in the human body. This is especially critical when producing therapeutic antibody fragments which need specific PTMs to ensure stability, solubility, and activity in therapeutic applications. Our WuXian™ Transient CHO system is derived from CHO-K1 cells and stands out for its high-titer expression capabilities, ensuring optimal protein yield in a shorter time frame.

Key Features of WuXian™ Transient Expression System

  • High Titer Expression: 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

From gene synthesis to purified proteins, WuXian™ Transient Expression platform delivers in 3-4 weeks.

WuXian™ Transient Service Details:

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

Case Study: High Titer of WuXian™ Transient Platform Delivers Grams of mAbs in 3 weeks

Figure A: The graph on the left illustrates the production of a commercial antibody using the WuXian Transient 3.0 system with multiple batches as a control. It demonstrates high-titer expression on both Day 4 and Day 7 of culture. The table on the right showcases the production capabilities of the same platform for three monoclonal antibodies, yielding approximately 1.5 g/L of high titer on Day 7 with a 5 mL culture. Following AC purification, the final yield reached approximately 6 g, with SEC Purity exceeding 95%.

Showcase the high titer production capabilities of the WuXian™ Transient platform for 3 monoclonal antibodies.

WuXian™ Transient expression system can be scaled up seamlessly for grams of mAb production in just 3 weeks.

Figure B: Using the WuXian™ Transient expression system, grams of mAb were produced in just 3 weeks. A mIgG2a was expressed in a 10 L culture using the WuXian™ Transient system and purified on Day 7 through AC and CEX. This process yielded 11.9 grams of target antibody. Further analysis with SEC-HPLC confirmed its purity at 98.8%.

WuXian™ Express (CHO Stable Pool) Expression System

 

The WuXian™ Express stable pool protein expression system can rapidly generate large amounts of proteins for early-stage drug discovery in just 4-7 weeks. Both WuXian™ Transient and WuXian™ Express platforms are derived from the CHO-K1 mammalian cell culture system, the same platform used in our WuXia®cell line development platform.

 

Using the same cell lines across all of these platforms provides comparable product quality attribute profiles and cell culture process performance. Therefore, the use of the WuXian™ platforms is ideal for conducting developability studies for the evaluation of multiple lead candidates and the subsequent seamless integration into stable monoclonal cell line development activities or for large-scale protein production required to support CMC product and process development activities.

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

WuXian™ Express Protein Production Platform: A Workflow and Timeline

The WuXian™ Express stable pool protein expression system can rapidly generate large amounts of proteins starting from gene synthesis in just 7 weeks.

Express (CHO) Service Details:

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

Case Study: High-Titer Expression of WuXian™ Express for Different Protein Types

 

This case study uses the WuXian™ Express platform to evaluate the production (i.e., titer: g/L) of antibodies and proteins at different cell culture scales.

Figure A: Using the WuXian™ Express platform, the expression of various proteins, including hIgG1/4, mIgG2a/2b, bsAb and Fusion proteins, all demonstrated high-titer expression >2 g/L with culture volumes ranging from 20 mL to 100 L.

Consistent high titer expression of various proteins using the WuXian™ Express platform.

  Timeline Average Yield (CHO) Expression Volume Features Request A Quote

Transient

 2-4 weeks 1 g/L 1 mL to 100 L
  • Start from codon optimization or customer provided DNA
  • Deliver product and QC data after 1-2 steps purification
 Request A Quote

Express

 5-7 weeks 3.5 g/L 20 mL to 100 L
  • Start from codon optimization or customer provided DNA
  • Deliver product and QC data after 1-2 steps purification

Frequently Asked Questions

Q: What expression system should I choose to produce Fab, VHH, scFv and other antibody fragments?

A: Fab, VHH, and scFv antibody fragments can be produced in various expression systems, including E. coli, yeast, and mammalian cells. The choice of expression system depends on the antibody fragment’s specific requirements. If the antibody fragment requires specific glycosylation or other post-translational modifications, or if it’s a fusion protein with a Fc region, mammalian expression system would be preferred. For smaller fragments that don’t require these modifications, and where quick production and high yields are essential, E. coli might be the preferred choice.

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

A: Our WuXian™ Transient and WuXian™ Express platforms consistently deliver high-titer expression for all antibody fragments, including Fab, VHH, and scFv. As an example, for VHH, our WuXian™ Transient platform can achieve a titer of 1 g/L on Day 4 and 2 g/L on Day 7, and WuXian Express™ can achieve an average titer of ~3 g/L.

Q: Is it easier to produce antibody fragments, like Fab, VHH, and scFv, compared to full-length mAb production?

A: Producing antibody fragments like Fab, VHH and scFv can be easier and more cost-effective compared to producing whole monoclonal antibodies for several reasons. First, antibody fragments are smaller in size, which often leads to higher expression levels and easier purification processes. Second, antibody fragments don’t require the formation of disulfide bonds in the heavy and light chains and don’t require post-translational modifications (e.g., glycosylation), and can therefore be produced in a wider range of expression systems.

Q: What is the advantage of developing antibody fragments, like Fab, VHH, and scFv over the full-length antibodies as therapeutics?

A: Developing Fab, VHH, and scFv fragments offers several advantages over full-length antibodies. Some of the primary reasons for generating antibody fragments include: improved tissue penetration due to smaller size, the ability to be engineered for specific purposes, reduced immunogenicity, and ease of production in bacterial systems.

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