Francis Galaway
Francis is a Quality (CMC) Assessor in the Biologicals team at the MHRA. His speciality is the licensing of Advanced Therapy Medicinal Products (ATMPs) for which he is a contributor to several guidance and pharmacopeial texts. Francis previously worked at the Wellcome Sanger Institute on intercellular interactions. The development of viral technology platforms for gene delivery was the subject of his PhD studies.
Appearances
DateNovember 19, 2024CQAs are essential attributes that must be monitored and controlled to ensure product quality. Understanding and defining CQAs has been challenging in the relatively new field of gene therapy, but is crucial to ensure patient safety and to meet regulatory standards…
