Built to scale: strategic considerations to meet production demands in cell and gene therapy

Stephen was appointed Chief Operating Officer of the Cell Therapy Catapult in January 2013. He brings over 20 years of biological medicine research, development, and manufacturing experience to the organisation. Stephen enjoys bringing cutting edge technologies to patients, by developing commercially viable products and has developed and validated scaleable, commercial manufacturing processes for cell based medicinal products, vaccines, and recombinant biologicals. Prior to joining the Cell Therapy Catapult, Stephen worked for a number of biotech and biopharma companies at Board level. Stephen was Development Director at both Onyvax and Stabilitech. At Stabilitech he led the exploitation of the company’s vaccine and biopharmaceutical stabilisation platform, and expanded it into the cell therapy arena. At Onyvax he played a key executive role in the Immune oncology programme, and at Medeva he worked on the hepatitis immunotherapy and antigen delivery platform. Stephen is passionate about securing and growing the cell and gene therapy manufacturing and development supply chain. He is the current Chair of the BIA’s Manufacturing Advisory Committee, actively promoting and supporting UK bio-manufacturing at Government as well as grass root level. He, also, sits on various academic Advisory Boards. His first degree was from the University of Birmingham, specialising in Infection and Immunity, and his second degree from the Medical School of Southampton University developing group B meningococcal vaccine candidates.

Heather has a Masters in Biochemical Engineering, with over 25 years’ experience in R&D, Quality, regulatory and business roles. For the last 10 years Heather has worked in the field of lentiviral vectors for ex vivo gene therapy and her current role as head of Commercial Operations for Lentigen is strategic planning for LV supply for customer contracts. This work includes planning for process scale up, process characterization, process validation and infrastructure upgrades to meet industry demands.