GMP ancillary materials for cell and gene therapy manufacturing: what to consider and when to make the switch
Have you ever wondered what to consider when you are selecting ancillary materials for your cell therapy clinical research? This webinar will cover regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support to enable successful clinical translation. As you move through clinical trials toward commercialization you’ll need solutions that can scale with you to meet the clinical need. The second part of this session, will address aspects you should consider now such as scalability, consistency of supply and commercial use rights to help clear your path to commercial manufacturing in the future.
Eric Roos has 30 years of experience in the development of biopharmaceuticals, cell therapy and tissue engineered products. He maintained a variety of responsibilities in the cell therapy industry supporting early phase development, process optimization, and clinical trial execution. His early controlled release, formulation, and biomaterials experience in transdermal, cytokine stimulated wound healing, and environmentally responsive hydrogels were leveraged to develop the encapsulated cell therapy and neural stem cell programs at CytoTherapeutics. His cell therapy experiences were then applied to develop commercial tissue engineering process technologies for wound healing products as leader of Process Development at Organogenesis. As Associate Director of Process Development at Bioheart Inc., he developed and tech transferred media and process improvements for the isolation and expansion of autologous myoblasts for clinical evaluation of a cardiac repair cell therapy. In his next roles as VP of Operations and Product/Process Development at Histogenics Corporation, he established the regulatory, process development, manufacturing, quality, and clinical systems for GMP production and clinical evaluation of an autologous tissue engineered cartilage repair product. Eric joined Thermo Fisher Scientific as part of Invitrogen in 2008 where his experiences were leveraged to identify global opportunities for platform development and adoption of industry enabling tools. He currently focuses on building Global Strategic Alliances and expanding the Cell & Gene Therapy Business Unit at Thermo Fisher Scientific. Eric holds a BSc. in Biochemistry from McGill University and has authored nine patents and a number of publications in the fields of drug delivery, biomaterials, cell therapy, and tissue engineering.