471157 Best Practices Identified While Transferring Lyophilized and Syringe Biologic Drug Products from Internal Site to a CMO

Wednesday, November 16, 2016: 9:36 AM
Union Square 3 & 4 (Hilton San Francisco Union Square)
Shilan Motamedvaziri, Manufacturing Science & Technology-Drug Product/ Biologics, Bristol-Myers Squibb, New Brunswick, NJ, Amol Mungikar, Manufacturing Science & Technplogy, Bristol-Myers Squibb Company, New Brunswick, NJ, Peter G. Millili, Manufacturing Science & Technplogy, Bristol-Myers Squibb, New Brunswick, NJ and Thomas Damratoski, Manufacturing Science and Technology, Manufacturing Science and Technology, New Brunswick, NJ

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.


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