Gene therapy CMC and quality control

Published: 22 October 2021
Foreword
Christine Le Bec

Christine Le Bec, PhD, joined Sensorion Pharma, a small biotech company, in early 2020 as Head of CMC Gene Therapy. She is responsible for CMC development (process and analytical development, product characterization) including non-clinical and clinical manufacturing, CMC transfer to CDMO/CRO and CMC regulatory issues. Prior to joining Sensorion Pharma, she worked for more than 20 years at Genethon, a French non-profit organization, in the field of Gene Therapy vectors (AAV, lentivirus, baculovirus) for rare diseases. She has a strong expertise in the development, qualification, validation of analytical methods for product characterization, release testing of gene therapy products and in stability studies. She also has a solid knowledge of international regulations and reviewing CMC documents for clinical applications.

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