Thursday, April 25, 2019 Daily Archives

eBook: Making Filtration Work

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Steady improvements in batch-fed cell culture have led to bottlenecks in downstream processing. Filter suppliers are working to improve available tools for purifying therapeutic proteins, to wring every possible efficiency out of those tools, and to make them operate together harmoniously. The combination of high titers and high-value products places a premium on preventing yield loss. Bioprocessors want to optimize filtration primarily for cost reasons. In this eBook, author Angelo DePalma discusses financial aspects, clarification/harvest and virus filtration options, and…

April 25, 2019

A Strategy to Remove Formulation Development from the Critical Path During Biologics Development

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Biopharmaceuticals tend to be highly unstable. Therefore, as the product development program progresses to phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage and clinical administration. Also, formulation development is often on the critical path to successful IND and BLA fillings. During this Q&A, Dr. Jun Lu, Director, Analytical Development, discusses how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development. Login and click View PDF to view the…

April 25, 2019

Novartis prepped for ‘unprecedented’ Zolgensma demand

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With over one million square-feet of manufacturing space, Novartis says it is prepared for the imminent approval of AveXis’ SMA gene therapy Zolgensma. Speaking during its Q1 2019 results, Novartis said it is set for the imminent arrival of gene therapy Zolgensma (onasemnogene abeparvovec), added to the firm’s pipeline through the acquisition of AveXis. The one-time therapy targeting spinal muscular atrophy (SMA) Type 1, will be reviewed by the US Food and Drug Administration in May, despite the recent news…

April 25, 2019