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CRO Services
Drug Development Expertise Empowering Research Services for Biologics

Monoclonal Antibody Production Services

High-Titer, Premium-Quality Monoclonal Antibody Production from High-Throughput to Gram Scale

 

WuXi Biologics CRO Services Department provides comprehensive monoclonal antibody production services for antibody drug discovery. Our custom antibody production capabilities leverage high-titer transient CHO expression systems to enable fast, cost-effective delivery, ranging from 1 mL small-scale high-throughput (HTP) production to 100 L large-scale production. Each year, we deliver 30,000+ high-quality monoclonal antibodies through our recombinant antibody production services, supporting clients across the entire drug discovery lifecycle.

 

 

 

High-Titer Custom Antibody
~ 2.6 g/L control antibody
Premium Quality
Purity >95%, endotoxin <0.5 EU/mg
Fast Timeline
Sequence to antibody in 3-4 weeks

 

 

Our four service platforms below are designed to address diverse mAb production needs from discovery to advanced preclinical research.

 

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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.

GramExpress: Gram-Level Antibody Production Services with Quality & Speed

 

Our GramExpress antibody production service delivers premium-quality monoclonal antibodies (mAbs) at the 1-100 g scale within 3-4 weeks. The platform integrates ultra-high-titer transient CHO expression with flexible, fit-for-purpose monoclonal antibody purification workflows to support a wide range of mAb programs. Using high-titer CHO cells and an optimized expression process, we achieve consistently high productivity. In a 7-day culture, expression levels reached up to 2.6 g/L using an internal control molecule. Purification workflows are customized based on small-scale pilot purification and in-process testing. This data-driven approach enables an optimized 2-3 step purification strategy for each target mAb, delivering exceptional product quality with >95% purity and endotoxin levels below 0.5 EU/mg, with molecular purity and identity verified by LC-MS.

 

Key Features of GramExpress Service:

  • Ultra-high titer WuXian Transient™ CHO Expression
  • Delivers 1-100 g of mAbs in 3-4 weeks
  • Premium quality verified by LC-MS (purity >95%, endotoxin <0.5 EU/mg)

GramExpress antibody production services provide gram-level yield, >95% purity,

GramExpress Service Details:

 

Production volume Scale Deliverables Timeline QC Project inquiry
Up to 100 L 1-100 g Gram-level purified monoclonal antibodies
(Construct generation, plasmid prep included)		 3-4 weeks LC-MS, SDS-PAGE (R/NR), SEC-HPLC,
and endotoxin test (<0.5 EU/mg)
Request a Quote

 

 

 

Case Study #1: Optimized GramExpress Workflow Enables 1-100 Grams Recombinant Antibody Production in Just 3-4 Weeks

 

This case study highlights the GramExpress’s capability for gram-level monoclonal antibody production within a 3-4 week turnaround timeline. Through a combination of codon optimization, high-titer transient CHO expression systems, and customized multi-step purification, the workflow consistently delivers >95% purity by SEC-HPLC and endotoxin levels below 0.5 EU/mg. Final products are further verified by LC-MS analysis to ensure structural integrity and molecular mass.

 

Optimized GramExpress workflow for large-scale monoclonal antibody production, integrating codon optimization, high-titer expression, and streamlined purification strategies to rapidly deliver gram-scale antibodies with high purity across multiple production scales.

 

Figure 1: Optimized GramExpress workflow enables rapid, scalable therapeutic antibody production. The top workflow highlights the optimization strategies behind the GramExpress platform, including bioinformatics-driven codon optimization, proprietary CHO cells​, and optimized transfection and cell culture processes to achieve ultra-high-titer CHO cell expression. Molecule 1 shows a monoclonal antibody purified using a three-column process (AC-AEX-CEX) at the 60 L scale, delivering ~80 g of target mAb within 4 weeks. The product achieved 98.5% purity as confirmed by SEC-HPLC and LC-MS, with endotoxin levels <0.02 EU/mg and an overall recovery of 76%. Molecule 2 demonstrates a recombinant antibody purified using a two-column process (AC-CEX) at the 10 L scale, yielding ~12 g of target mAb within 4 weeks. The final product reached 98.8% purity by SEC-HPLC with endotoxin levels <0.16 EU/mg.

 

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777: Low-Endotoxin, Low-Aggregate Custom Antibody Production Services

 

The 777 service utilizes our high-titer transient CHO expression system to deliver high-quality recombinant antibodies with low endotoxin (<0.5 EU/mg) and low aggregation (>95% monomer), ideal for both in vitro and in vivo applications. Following a 7-7-7 workflow, this service completes the full production cycle in just 3 weeks: 7 days for construct generation, 7 days for protein expression with ~1 g/L average mAb titer, and 7 days for purification and QC.

 

Key Features of 777 Service:

  • Premium quality with low aggregates (>95% monomer) and low endotoxin (<0.5 EU/mg)
  • Multiple production scales available: 20 mL (3-10 mg); 100 mL (15-100 mg); 200 mL (30-200 mg)
  • Suitable for most in vitro and in vivo studies

777 utilizes 7 days for construct generation, 7 days for CHO expression with 1 g/L titer, and 7 days for purification & QC, enabling HTP production of low aggregates (>95% monomer) and low endotoxin (

777 Service Details:

 

Production volume Scale* Deliverables Timeline QC ** Project inquiry
20 mL
CHO/HEK293		 3-10 mg Purified monoclonal antibodies

(Construct generation, plasmid prep included)
 3 weeks Titer, Caliper (R/NR) or SDS-PAGE (R/NR), SEC-HPLC, and endotoxin test (<0.5 EU/mg)
Request a Quote
100 mL
CHO/HEK293		 15-100 mg
500 mL
CHO/HEK293		 30-200 mg

 

*Yields are dependent on molecules
**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.

 

Graph shows antibody production achieving 0.7 g/L titer after two-step purification with low endotoxin (0.015 EU/mg).

 

Figure 1: The 777 platform achieved an average titer of 0.7 g/L and an average monomer purity of 99.8% following two-step automated purification, while maintaining endotoxin levels below 0.1 EU/mg, without the need for a separate endotoxin removal step.

 

 

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

 

This case study represents the 777 platform’s ability to produce therapeutic monoclonal antibodies of exceptional purity, as confirmed by SEC-HPLC and Caliper-SDS.

 

These SEC-HPLC and Caliper-SDS data highlight the high purity of monoclonal antibodies produced using the 777 platform.

 

Figure 2: SEC-HPLC and Caliper-SDS data highlighting the extremely high purity and low aggregation (>99% monomer) of vanilla antibodies produced via the 777 platform.

 

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

 

Ultra 96+ is a fast and cost-effective custom antibody production platform that can dramatically accelerate your early-stage drug discovery timelines by producing hundreds to thousands of antibodies in just 3 weeks. Built on our innovative high-titer transient CHO expression system, the service integrates and automates the transfection, expression, purification, and QC of antibodies in 96 or 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-high-throughput antibody production with 1,000 antibodies/day
  • Automated transfection, expression, and purification in one integrated platform
  • 1-3 mL 96 or 24 deep-well plates, yielding 100-1,500 µg antibody/well

Ultra 96+ is a fast and cost-effective custom monoclonal 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.

 

 

Automated HTP monoclonal antibody production system for Ultra 96+ Service

Ultra 96+ Service Details:

Production Volume Scale Deliverables Timeline QC Project Inquiry
96 × 0.8 mL
CHO/HEK293		 100-800 μg Purified monoclonal antibodies
(Construct generation, plasmid prep included)		 3 weeks Titer, Caliper (R/NR), and SEC-HPLC
Request a Quote
24 × 3 mL
CHO/HEK293		 0.5-2 mg

 

 

Case Study #1: High-Titer & High-Recovery Recombinant Antibody Production Using the Ultra 96+ Platform

 

The Ultra 96+ platform demonstrates exceptional high-titer expression and recovery across diverse antibody formats, including monoclonal antibodies and Fc-fusion proteins.

 

High-titer monoclonal antibody and Fc-fusion protein production in 1 mL CHO cultures using 96-deep-well plates, demonstrating high recovery rates (83% in 96 DWP and 84% in 24 DWP formats).

 

Figure 1: Ultra 96+ enables high-titer expression and high recovery across diverse antibody formats. (A) Average titer of control antibodies, monoclonal antibodies, and Fc-fusion proteins in 1 mL CHO culture using 96 DWP, showing consistently high-titers across various constructs. (B) An average recovery rate of 83% in 1 mL (96 DWP) and 84% in 3 mL (24 DWP) CHO cultures, ensuring consistently high yield and quality.

 

 

Case Study #2: Ultra-High-Throughput, High-Titer Expression of Therapeutic Monoclonal Antibodies

 

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

 

High-titer monoclonal antibody and Fc-fusion protein production in 1 mL CHO cultures using 96-deep-well plates, demonstrating high recovery rates (83% in 96 DWP and 84% in 24 DWP formats).

 

Figure 2: In 1 mL 96-DWP CHO cultures, the Ultra 96+ platform achieved impressive mean yields of 1.2 mg for 960 antibodies, 0.98 mg for 536 VHH-Fc, 0.55 mg for 557 Flag-Fab, and 0.3 mg for 100 His-VHH. The proteins are well-suited for in vitro assays.

 

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WuXian Express™: Large-Scale Antibody Production Services Using High-Titer CHO Stable Pool

 

For large-scale monoclonal antibody production using stable pools, WuXi Biologics offers WuXian Express™ (CHO Stable Pool) antibody production services, built on the same parental CHO cell line to enable seamless scale-up and strong comparability to stable cell line conditions. This cost-effective and efficient platform supports a streamlined workflow from construct design through purification and QC, delivering high-quality recombinant antibodies and proteins within 4-7 weeks. WuXian Express™ provides reliable performance, flexible scaling, and a robust foundation for downstream CMC development.

 

 

Key Benefits

  • Fast and Cost-Effective Delivery: Purified proteins delivered in as little as 4–7 weeks through an optimized CHO stable pool workflow.
  • High Consistency and Quality: <10% pool-to-pool titer variation with research-grade quality comparable to transient expression systems.
  • Scalable and CMC-Ready: Flexible production from 20 mL to 100 L, achieving titers >2 mg/mL and supporting smooth transition to stable cell line development.

 

Learn About WuXian Express™ Platform

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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