CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.
|Podcasts|November 22, 2021
Scale-out Manufacturing – A Critical Risk Mitigation Strategy for Biologics Production
Author(s)WuXi Biologics
Changes in production scale required due to increasing product needs throughout clinical trials introduces risk to the product development timeline. Both the process and the product can be dramatically impacted from scaling-up to larger production volumes. Once in commercial manufacturing, sudden changes to product demand in either direction can have costly consequences if the scale of production chosen is not adequate to meet the changing material requirements. Adapting a “scale-out” instead of “scale-up” strategy for clinical and commercial production can greatly minimize these risks. This podcast will review the scale-out biomanufacturing approach and the significant benefits of this production paradigm.
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