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Offering End-to-End Solutions
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
Continuous Processing 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:
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.