Comparability
Leveraging Risk Assessment for Demonstrating Product Comparability after Manufacturing Process Changes
Pawel Stanczak, Ph.D.; Xuemei Han, Ph.D.; Miguel Carrion
Tanvex CDMO
PAO-07-24-CL-08Aug 26, 2024
Gene Therapy
Building a Bridge of Equivalence to Facilitate and Implement Rapid Process Changes in Gene Therapy Manufacturing
Wade Macedone; Jonathan Rush; Phillip Vermilion; Samir Acharya, Ph.D.
Andelyn Biosciences
PAO-10-21-CL-01Oct 07, 2021