Article | March 11, 2019

Best Practices For Ensuring Quality In Biologic Products

By Susan M. Dounce, Ph.D.

New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. Whether the challenge is to provide robust cryopreservation containment for gene or cell therapies, to develop wearable injectors to transition oncology mAbs out of infusion clinics and into a home setting, or to modernize the packaging systems used by 503B outsourcing facilities, there are several universal best practices for ensuring the quality of the biologic product.

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