Troubleshooting quality assurance for AAV raw & starting materials

Biswarup DasGupta (Bis) is a Quality and Compliance leader with experience in QA, QC including contamination control over 20 years in the Biotech Industry. Recently, Bis worked as QA Director for Sarepta’s Gene Therapy program, since July 2019. Before Sarepta, Bis assumed different roles in Quality organization with increasing responsibilities at Sanofi, GSK Biologics, and Altana Pharma. In these roles, he has developed effective contamination control programs, led successful CD verification, implemented phase-appropriate GMPs, provided strategic leadership, and built a culture of quality and continuous improvement. Bis has a master’s in Microbiology and BS in Chemistry, Biology, and Microbiology. Bis has co-authored TR13-2 and currently co-leading the new TR on Contamination Control Strategy. Bis is also a member of the current revision of TR-56.