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

Efficient and effective scale-up of production for viral vectors and allogeneic cell therapies and scale-out of production for autologous cell therapies are absolutely key to the development of commercially viable products. This webinar provides an opportunity to hear from leading experts:

Dr Stephen Ward, Chief Operating Officer, Cell and Gene Therapy Catapult, UK
Dr Ian Gaudet, Director of Process Development, Miltenyi Biotec, USA
Ms Heather Embree, Director, Commercial Operations, Lentigen, USA

They share their insights and experiences in addressing the myriad challenges of effective scalability of cell and gene therapies, including:

Examining innovative concepts and solutions for up-scaling cell and viral vector production to meet future demands
Evaluating scalability, yield, quality and cost-effectiveness of current and next-generation cell and viral vector production platforms
Choosing the right cell engineering platforms: what are the implications for your downstream process and product?
Integrating feedback and -forward loops to optimize cell and gene therapy manufacturing processes and products: challenges and opportunities

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Dr Stephen Ward

Chief Operating Officer, Cell and Gene Therapy Catapult, UK

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.

Dr Ian Gaudet

Director of Process Development, Miltenyi Biotec, US

Dr. Ian Gaudet studied Bioengineering at the University of California, San Diego, and received his doctorate in Biomedical Engineering jointly from Rutgers University and the University of Medicine and Dentistry of New Jersey, with work focused on novel biomaterials for regenerative medicine applications. Following his Ph.D., Dr. Gaudet worked for Progenitor Cell Therapy (PCT) where he was the Sr. Engineer and then Director of Innovation and Engineering, leading a scientific and engineering team in support of design, development, and implementation of clinical cell therapy manufacturing processes, as well as cell therapy commercialization strategy consulting. Dr. Gaudet led multiple projects from tech transfer, through development, and into clinical manufacturing, including multiple gene-modified hematopoietic stem cell and T cell therapies. He joined Miltenyi Biotec in 2016 and is currently the Director of Process Development at Miltenyi’s contract development and manufacturing facility in Sunnyvale, CA, where he focuses on development and translation of novel cell therapy processes into clinical manufacturing and beyond.

Ms Heather Embree

Director of Operations, Lentigen, USA

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.

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