Embarking Upon the Commercial Manufacturing Journey For a Biologic: Strategies to Achieve Successful Approval & Launch
Summary: There are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In some cases, there is a need to identify a partner to support this next stage in a product’s life cycle. In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.