Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use Bioreactors


11th March 2019 | 10.00am EST | Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences, AbbVie Bioresearch Center |ATTEND FREE WEBINAR

Summary
A systematic scale-up strategy is critical in enabling a rapid and robust technical transfer. For a program involving a CHO cell culture process, a combination of mass-transfer (kLa) studies, computational simulation and scale-down model experiments were used within this newly developed work-flow. Utilizing this approach, scale-up was successfully accelerated (<4 months) with titer improvement and comparable product quality. The main lessons learned from this case study will be presented.

Presented by Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences, AbbVie Bioresearch Center

Ying Wang is currently a Senior Scientist in the Manufacturing Sciences department at AbbVie Bioresearch Center in Worcester, MA, USA. He got his Bachelor’s and Master’s degree in Chemical Engineering at Tsinghua University, China. He got his PhD degree in Chemical and Biomolecular Engineering at Johns Hopkins University, USA, and joined AbbVie in 2015. His research focuses on the development of bioprocesses based on biological understandings and engineering methods using mammalian cells for producing recombinant proteins and monoclonal antibodies. His expertise is in biologics production from Chinese hamster ovary (CHO) cell culture, especially for upstream process development and scale-up. He had experience in multiple commercial and late clinical stage biologic products (including mAbs and fusion proteins), performing technology transfer, cell culture process validation, scale-down model qualification, bioreactor kLa studies, and driving innovative study in metabolic pathways. He also had experience on authoring sections and providing technical support for BLA filing, regulatory audits and response to the comments from agencies. He has also had research experience during his PhD study, which focused on human induced pluripotent stem cells, gene editing, stem cell differentiation for translational medicine.


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