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Protein Sciences

Uniting Drug Development Expertise with Antibody & Protein Production Services

Monoclonal Antibody Production

Supporting Your Monoclonal Antibody Production Needs

 

WuXi Biologics’ Protein Sciences (PS) Department provides comprehensive early-stage R&D antibody production services to meet your unique monoclonal antibody (mAb) production schedule and requirements. Our high-titer expression systems ensure fast and cost-effective production, from 1 mL small-scale, high-throughput (HTP) production to 100 L large-scale production. We produce more than 5,000 high-quality mAbs per year for our clients throughout the entire drug development process. Our four service platforms below cater to all your mAb production needs.

Harness our high-titer expression systems for high-purity, low-endotoxin mAb production in a fast and cost-effective way, from 1 mL to 100 L.

Ultra 96: Ultra-High-Throughput (uHTP) Antibody Production Services

 

Ultra 96 is a fast and cost-effective antibody production platform that can dramatically accelerate your early-stage drug development timelines by producing hundreds to thousands of antibodies in just 3 weeks. The innovative service integrates and automates the transfection, expression, purification, and QC of antibodies in 96 and 24 deep-well plates, resulting in a daily production throughput of ~1,000 antibodies at 100 -1,500 ug each, suitable for in vitro assays.

 

Key Features of Ultra 96 Service:

  • Ultra HTP monoclonal antibody production with a daily throughput of 1,000 molecules
  • Automated transfection, expression, and purification in one integrated platform
  • 1-3 mL cell culture, yielding 100-1,500 ug antibody/wells

Ultra 96 is a fast and cost-effective antibody production platform that can produce hundreds to thousands of antibodies in just 3 weeks.

Ultra 96 provides a daily production throughput of ~1,000 antibodies at 100 -1,500 ug each, suitable for in vitro assays.

Ultra 96 Service Details:

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

Case Study #1: High Titer & High Recovery Rates of the Ultra 96 Platform

 

This case study demonstrates the high titer and high recovery rates achieved using the Ultra 96 platform in the production of antibodies. The first figure highlights the platform’s high-titer production capabilities of monoclonal antibodies, bispecific antibodies, and Fc fusion proteins in the 96 DWP at 1 mL culture volume. The second figure shows an 83% recovery rate for both 1 mL culture using 96 DWP and 3 mL culture using 24 DWP.

Figure A: The average titer of monoclonal and bispecific antibody and Fc fusion protein production using the Ultra 96 platform. High-titer production was accomplished across all three types of antibodies in the 96 DWP at 1 mL culture volume.

This shows Ultra 96’s high-titer production capabilities of mAbs, bispecific antibodies, and Fc fusion proteins in 96 DWP at 1 mL culture volume.

Figure B: An average recovery rate of 83% or more was achieved in both 1 mL culture using 96 DWP and 3 mL culture using 24 DWP.

This shows an 83% recovery rate for both 1 mL culture using 96 DWP and 3 mL culture using 24 DWP.

Case Study #2: High-Titer Expression of AI-Designed Antibody Drug Molecules Using the Ultra 96 Platform

 

The use of artificial intelligence (AI) in antibody drug development has demonstrated significant benefits in recent years. These AI projects typically begin with the generation of thousands of molecules that must be produced and experimentally tested, necessitating HTP production in a cost-effective manner. Our Ultra 96 platform is designed to meet this need, as demonstrated in the case studies below.

Figure A: The Ultra 96 platform maintained consistent high-titer expression in 1 mL culture using 96-DWP for some AI-designed molecules (853 Abs). Figure B: The expression of His-VHH (88 Abs) and mAb (60 Abs) both showed high-titer expression, with average final yields of 3.1 mg and 1.8 mg respectively.

Figure A: For HTP antibody production, the Ultra 96 platform maintained consistent high-titer expression in 1 mL culture using 96-DWP for some AI-designed molecules (853 Abs), and the protein after one-step purification is suitable for in vitro assays

 

Figure B: Using our Ultra 96 platform, the expression of His-VHH (88 Abs) and mAb (60 Abs) both showed high-titer expression, with average final yields of 3.1 mg and 1.8 mg respectively, generated from 3 mL culture in 24-DWP.

7-7-7 Platform: Low Endotoxin & Low Aggregate Antibody Production

 

Our expedited 7-7-7 mammalian transient production service can provide antibodies that have low endotoxin (<0.5 EU/mg) and aggregate (>95% monomer) levels at 1-100 mg scale, suitable for both in vitro and in vivo studies

 

  • 7 days for gene synthesis
  • 7 days for protein expression (average mAb Titer 900 mg/L)
  • 7 days for purification and QC (low endotoxin <0.5 EU/mg, and low aggregation >95% monomer)

Key Features of 7-7-7 Service:

High-quality antibody is suitable for most in vitro and in vivo studies.

 

  • Low aggregation (>99% monomer)
  • Low endotoxin (<0.5 EU/mg)
  • Many production scales are available (yields are dependent on molecules)
    • 100-700mg
    • 20 mL (3-10mg)
    • 200 mL (30-100mg)
    • 500 mL (50-250mg)
    • 1 L (200-500mg)
    • 2 L (500-1000mg)

7-7-7 produces antibodies that have low endotoxin (<0.5 EU/mg) and aggregate (>95% monomer) levels at 1-100 mg scale, suitable for both in vitro and in vivo studies.

7-7-7 Service Details:

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
1 L
CHO/HEK293		 400-1000 mg 3 weeks
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 #1: High Titer, Low Endotoxin and Low Aggregates Antibody Production Using the 7-7-7 Platform

 

This case study highlights the successful production of 170 IgG antibodies using our 7-7-7 platform from 20 mL CHO cell cultures in the early discovery phase.

Figure A: A high average yield of 225 mg/L was achieved after 2-step automated purification process, while maintaining endotoxin levels <0.1 EU/mg, without the need for a separate endotoxin removal step.

Graph shows high average yield of 225 mg/L was achieved after 2-step automated purification process, while maintaining endotoxin levels <0.1 EU/mg.

Case Study #2: High-Purity Monoclonal Antibody Production Confirmed by SEC-HPLC and Caliper-SDS Data

 

This case study demonstrates the 7-7-7 platform’s ability to produce vanilla antibodies of exceptional purity, as confirmed by SEC-HPLC and Caliper-SDS

Figure A: SEC-HPLC and Caliper-SDS data highlighting the extremely high purity of vanilla antibodies produced using the 7-7-7 platform.

These EC-HPLC and Caliper-SDS data highlight the extremely high purity of monoclonal antibodies produced using the 7-7-7 platform.

GramExpress Service: Large-Scale Monoclonal Antibody Production

 

Our GramExpress service is designed to produce premium-quality monoclonal antibodies (mAbs) ranging from 1-100 grams in 3-4 weeks. The platform synergizes ultra-high titer transient expression with flexible purification processes. We have developed host cells with a remarkable capacity for high-titer expression and have optimized the expression process. As evidence of this, we have achieved an expression level of 2.2 grams of mAbs per liter, using an internal control molecule as a benchmark. The purification phase employs a series of 2-3 purification steps using columns of different sizes to isolate the target mAbs. To uphold our rigorous standard, small-scale purification and in-process testing are conducted throughout, ensuring the production of high-quality mAbs on a large scale.

 

Key Features of GramExpress Service:

  • Ultra-high titer WuXian™ Transient Expression
  • Delivers 1-100 g of mAbs in 3-4 weeks
  • Premium quality (purity >98%, endotoxin <0.2 EU/mg)

GramExpress Service Details:

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

Analysis: LC-MS, SDS-PAGE, SEC-HPLC, Endotoxin

Case Study:

Figure A: Optimization strategies for GramExpress large-scale mAb production. The optimization process encompassed multiple stages, commencing with bioinformatics and host clone selection, and extending through transfection and cell culture phases, all aimed at achieving ultra-high titer expression.

Optimization strategies for GramExpress large-scale mAb production.

An example of a monoclonal antibody purified by 3 column steps (AC-AEX-CEX) at 60 L scale.

Figure B: An example of a mAb purified by 3 column steps (AC-AEX-CEX) at 60 L scale. ~79 grams of target mAb was delivered within 4 weeks (1 week for DNA synthesis and plasmid preparation, 1 week for expression, 2 weeks for purification and QC). The results showcase an SEC-HPLC purity of 99%, endotoxin levels <0.02 EU/mg, and an overall recovery rate of 76%.

Figure C: A demonstration of a protein purified using 2 column steps (AC-CEX) at a 10 L scale. The process yielded ~12 grams of purified target protein within 3 weeks (1 week each for DNA preparation, expression, and purification/QC). The protein achieved an SEC-HPLC purity of 99% with endotoxin levels <0.16 EU/mg.

A demonstration of a protein purified using 2 column steps (AC-CEX) at a 10 L scale.

Large-Scale Monoclonal Antibody Production Using Stable Pool

 

For your large-scale monoclonal antibody production using stable pool, WuXi Biologics offers the WuXian™ Express (CHO Stable Pool) platforms that use the same CHO cell line for seamless scale-up production. To learn more about the service, please click here.

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 protein A purification. For the 7-7-7 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 7-7-7 services?

A: For the Ultra 96 and 7-7-7 platforms, vanilla antibodies (e.g., hIgG1, hIgG4, mIgG1, mIgG2a) are most suitable. For other types of mAbs.

 

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 ug 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 7-7-7 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.

 

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