Preparing For The Green Light: Considerations For Post-Approval Biologics Manufacturing

The development process for a vaccine or biologic can be complicated and costly, often involving a lengthy and time-consuming journey spanning several years. Following clinical development and in preparation for approval, it is essential to plan for the commercial manufacturing of your cell culture media. This will allow you to maintain the highest levels of quality and efficiency in your process at a commercial scale. Following approval, this forward-thinking and preemptive planning will help you avoid excessive costs and continue to produce consistently into the future [1].

The following are considerations you should not overlook before, during, and after clinical trials.