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Downstream Process Development
WuXi Biologic’s Downstream Process Development (DSPD) team applies state-of-the-art technology in purification process development, process scale-up, process characterization, and technology transfer to cGMP production. DSDP has extensive experience developing purification schemes for a wide-variety of biologics including: monoclonal antibodies, bispecific antibodies, Fc-fusion proteins, antibody drug conjugates, recombinant proteins and antibody fragments.
Product Types Purified by DSPD
- Team
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- The DSPD team comprises over 140 talented, highly-trained scientists, with greater than 85% holding advanced degrees. In 2020, we have over 50 function leads (FLs) managing more than 100 CMC projects.
- Lab
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- DSPD has more than 1,000 m2 (11,000 ft2) of lab space dedicated to bench-scale process development and access to an additional 800 m2 (8,600 ft2) in the non-GMP pilot plant. Both areas are equipped with state-of-the-art instruments for processing protein therapeutics.
- Monoclonal Antibody (mAb) Downstream Process Platform
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- For a typical monoclonal antibody process development program, the DSPD team implements a well-established platform process, including harvest clarification, Protein A affinity chromatography, solvent/detergent and/or low pH virus inactivation, one or two ion-exchange chromatography, viral filtration, and ultrafiltration/diafiltration steps. We typically deliver a reliable and scalable downstream process in an 8-12-week timeline.
- For a typical monoclonal antibody process development program, the DSPD team implements a well-established platform process, including harvest clarification, Protein A affinity chromatography, solvent/detergent and/or low pH virus inactivation, one or two ion-exchange chromatography, viral filtration, and ultrafiltration/diafiltration steps. We typically deliver a reliable and scalable downstream process in an 8-12-week timeline.
- Non-mAb Downstream Process Platform
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- The DSPD team is capable of developing cGMP purification process for a wide-range of biologics and vaccine products and a customized purification process can be developed to meet our customers’ needs. An array of chromatographic resins, including affinity, ion exchange, hydrophobic interaction, hydroxyapatite, mix-mode etc., can be screened. These non-mAb downstream process development activities can be completed within a 12-24-week timeline.
- High Throughput Process Development Platform
- Continuous Processing Platform
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- WuXi Biologics DSDP team of experts can establish new purification schemes or convert batch processes to a continuous process. We can work with our Upstream Cell Culture Process Development team to integrate downstream continuous process operations as part of our WuXiUPTM technology platform. (Click here to learn more about our WuXiUPTM Technology Platform Services)
- For clients entering commercial-scale manufacturing, we offer the WuXiUI™ Ultra-intensified fed-batch platform which has been shown to reduce cost of goods by 60-80% as an additional option.
Continuous Processing Platform
- Reduction Risk Evaluation Platform
To the support our client’s fully-integrated biologics development programs, we offer customized stand-alone services to either develop entire purification schemes or single unit step operations or processes. The scope of our services include:
- Purification Support:
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- Purification services to support clone selection and cell culture development
- Drug substance generation to support analytical and formulation development activities
- Early Phase Downstream Process Development:
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- Bench-scale process development
- Process scale-up in non-GMP pilot plant
- Technology transfer for GMP production
- Viral clearance studies
- Late Phase Downstream Process Optimization:
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- Process optimization
- Failure Modes and Effects Analysis (FMEA)
- Scale-down model qualification for process characterization
- Process characterization
- Late phase viral clearance study
Typical Equipment/Instruments Available in the WuXi Biologics DSPD labs
Examples of AKTA Chromatography Systems Available in DSPD Labs
We work closely with our customers to define product specifications, and conduct downstream development in parallel with upstream, analytical and formulation development activities to ensure an integrated process development program. We offer industry leading timelines development timelines and partner with our client’s to establish appropriate milestones and work diligently to meet expectations. We have successfully developed and transferred into cGMP manufacture more than 120 downstream processes for our global clients.
Downstream Process Development Projects
During the 2020 coronavirus pandemic, we worked together with our worldwide clients on over 10 different downstream processes for neutralizing antibody and vaccines targeted to COVID-19. DSPD played a critical role along other teams in WuXi Biologics on these crucial therapeutics and vaccines to get the products to IND filing in 3-6 months from the time we received the DNA sequences. Our expertise and extensive experience enabled the delivery of robust processes within one month without compromising quality or product safety. DSPD’s commitment to rapid and high quality services enable WuXi Biologics’ global clients to make our world a better place.