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Borys, Michael

Khetan, Anurag

Ou, Jianfa

Rittershaus, Emily

Siddiquee, Khandaker

Tang, Yawen

Xu, Jianlin

English

Engineering Conferences International

 Poster Number 21 NEXT GENERATION PERFUSION PROCESS DEVELOPMENT FOR PRODUCTION OF BIOLOGICS  Jianlin Xu, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA jianlin.xu@bms.com Jianfa Ou, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA Yawen Tang, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA Khandaker Siddiquee, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA Emily Rittershaus, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA Michael Borys, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA Anurag Khetan, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, USA   Key Words: fed-batch cell culture, N-1 and production perfusion, cost of goods, comparability of quality attributes, productivity  Process intensification by perfusion cell culture at the N-1 seed and N-stage production steps has been developed for biomanufacturing in the pharmaceutical industry recently. In this case study, a traditional fed-batch cell culture process is currently used in manufacturing of a monoclonal antibody. To address much higher projected drug substance demands at peak sale years, different process intensification strategies are being evaluated as next generation process options for future mAb manufacturing. These strategies include N-1 seed perfusion, steady state perfusion, and non-steady state dynamic perfusion at N production step. Data on productivity improvement, comparability of different quality attributes, scale-up method, facility fit, and cost of goods will be presented to compare different next generation perfusion process options.  

Next generation perfusion process development for production of biologics

https://dc.engconfintl.org/cgi/viewcontent.cgi?filename=0&article=1054&context=biomanufact_v&type=additional

Next generation perfusion process development for production of biologics

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Engineering Conferences International