Strategies to Achieve Successful Approval & Launch

There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch into European markets. In some cases, there is a need to identify a partner to support the product’s lifecycle. 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.