Capstone Projects

Decommissioning of a Biopharmaceutical Manufacturing Facility (A Case Study)

Program: Applied Biotechnology Master's — Quality Assurance and Compliance
Host Company: Agenus
Location: Berkely, California (onsite)
Student: Jennifer Lynn Eslick

GMP regulations and ICH guidelines do not specifically address the decommissioning of a biopharmaceutical manufacturing facility. Risk assessment and the Quality System element of change management work together as a system to ensure that equipment and systems either remain in a validated state, or defined a path to return idle equipment, systems, and routine activities back to full GMP status for future production. Presented is a case study to place a clinical stage biopharmaceutical company into an idle state, that meets regulatory expectations, and allows for a future return to GMP manufacturing.