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Achieving Integrated Biologics Development: Challenges and How to Tackle Them

Summary: A comprehensive end-to-end solution from biologics development, clinical to commercial-scale manufacturing and finished product supply has the potential to provide higher quality and improved yield of biopharmaceuticals with reduced cost and time. Compared to small molecules, the selection, characterization, drug substance manufacturing and drug product development are all more complex. Decisions during early development can have an impact on the likelihood of clinical and commercial success. Therefore, it is important to understand the integrated nature of biologics development.

This webinar will focus on key considerations for transitioning a molecule from clinical to commercial beginning with cell line development and biomanufacturing to formulation and filling, followed by management of clinical study supplies.

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