Kathleen Francissen

Several cell and gene therapy products have received marketing approval from health authorities and, with that, a more complete picture is now emerging about the regulatory CMC requirements to commercialize these products…

Gene Therapy Drug Development for Ultra-Rare Disease: Challenges & Opportunities

Comparability assessments are necessary for life cycle management of all biological products, including cell and gene therapies (CGT), and are conducted to ensure that manufacturing changes do not adversely impact product quality, safety, or efficacy…