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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 µg 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 µg 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 μg 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 antibody and Fc fusion protein production using the Ultra 96+ platform. High-titer production was accomplished with both types of antibodies in the 96 DWP at 1 mL culture volume.

This shows Ultra 96+’s high-titer production capabilities of monoclonal antibodies, 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 Antibody Drug Molecules Using the Ultra 96+ Platform

 

Our Ultra 96+ platform provides high-throughput (HTP) antibody production with a daily production of over a thousand antibodies. This advanced platform incorporates an ultra-high titer transient CHO expression system that significantly enhances titers and overall yields, as demonstrated below.

The Ultra 96 platform maintained consistent high-titer, high throughput (HTP) expression in 1 mL culture using 96-DWP for antibodies, Fc-fusion VHHs, Flag-Fabs and His-VHHs.

Figure A: The Ultra 96+ platform offers remarkable mean final yield of antibody drug molecules in in 1 mL culture using 96-DWP, achieving 1.2 mg for 960 antibodies, 0.98 mg for 536 VHH-Fc, 0.55 mg for 557 Fab, and 0.3 mg for 100 His-VHH. The proteins are suitable for in vitro assays.

777 Platform: Low Endotoxin & Low Aggregate Antibody Production

 

Our expedited 777 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 777 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)
    • 20 mL (3-10mg)
    • 100 ml (15-100mg)
    • 200 ml (30-200mg)
    • 500 ml (100-500mg)

777 utilize 7 days for DNA systhesis, 7 days for expression with over 0.7 g/L titer and 7 days for purification & QC. 777 alows HTP production of low aggregates (>95% monomer) and low endotoxin (<0.5EU/mg) antibodies in 3 weeks at 20-500 mL scale, suitable for both in vitro and in vivo studies.

777 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
500 mL
CHO/HEK293		 100-500 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 777 Platform

 

This case study highlights the successful production of 170 IgG antibodies using our 777 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 777 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 777 platform.

These EC-HPLC and Caliper-SDS data highlight the extremely high purity of monoclonal antibodies produced using the 777 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 including bioinformatics codon optimization, host selection, transfection process and cultivation process.

An example of a monoclonal antibody purified by 3 column steps (AC-AEX-CEX) at 60 L scale, yielding ~79 grams with a purity of 99%.

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, yielded ~12 grams with a purity of 99%.

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 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.

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