(501d) Best Practices Identified While Transferring Lyophilized and Syringe Biologic Drug Products from Internal Site to a CMO

In this presentation, lessons learned while transferring Lyophilized and Syringe biologic drug products to a new site will be shared. The goal is to go over the critical quality attributes of the selected commercial drug product and identify best practices to maintain those attributes in the new commercial site. During the technology transfer to a second commercial site post-approval, the firm might find opportunities to improve the current manufacturing process and face challenges to implement these changes due to regulatory requirements. This presentation will cover some of those challenges as well.