Embarking Upon The Commercial Manufacturing Journey For A Biologic: Strategies To Achieve Successful Approval & Launch

Bringing a biologic to market is not easy, and 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. Many biopharma companies choose to partner with a contract provider for commercial launch and manufacturing. In some cases, they have performed development inhouse or have been working with a development partner that does not have the commercial launch and manufacturing capabilities to support the next steps. Therefore, there is a need to identify a new partner to support this next stage in the product’s life cycle, and the brand owner should have a clear understanding of their requirements if a successful manufacturing partnership is to be formed. 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.