CELL & GENE THERAPY INSIGHTS

Gene therapy CMC and quality control

Guest Editor:
Christine Le Bec, Head, CMC, Gene Therapy at Sensorion
Christine Le Bec
Head, CMC, Gene Therapy at Sensorion
CHRISTINE LE BEC joined Sensorion Pharma in early 2020<br />as Head of CMC Gene Therapy. She is responsible for all CMC<br />activities, including pre-clinical development, CMC transfer to<br />CMOS, manufacturing and supplying of Phase 1 and 2 clinical<br />trails. Before joining Sensorion Pharma, she worked for more<br />than 20 years at Genethon in the field of Gene Therapy vectors<br />(AAV, Lentivirus, Baculovirus) for rare diseases. She has a strong<br />expertise in the development, qualification, validation of analytical<br />methods for product characterization, release testing of<br />gene therapy products and in stability studies. She has also a solid<br />knowledge of International regulations and reviewing CMC documents<br />for clinical trial applications.
October 2021