Aseptic Manufacturing Process

This project introduced the team to a foundational part of biopharmaceutical manufacturing: Downstream Purification. The objective of this project was to provide research deliverables to a CDMO regarding technology requirements, market and competitor research, and regulatory guidelines for establishing a downstream Aseptic Manufacturing Process (AMP) for viral vector purification. Through in-depth research, comparative analysis, key opinion leader outreach, and literature search, the team was able to deliver on the requested items defined by the industry mentor, Fujifilm Diosynth Biotechnologies.