Gene therapy CMC and quality control

Abstract

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://bioinsights.blob.core.windows.net/uploads/Photo Christine_LEBEC copy.jpg" data-image="1"></div><div class="author-det"> <b>Christine Le Bec</b>, 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. </div></div></div>