by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. This draft guidance document, when finalized...
Sponsored Content from Stemcell Technologies The cell and gene therapy field is rapidly advancing as shown by the growing number of clinical trials and regulatory-approved therapies.¹ As the breadth of cell types, technology platforms, and target diseases continues to evolve, so too...
by Laine Bodnar Senior Manager Communications CCRM Whether you’ve visited Canada or not, you probably know that it’s famous for beautiful scenery, maple syrup and ice hockey. Canada is also where Drs. James Till and Ernest McCulloch defined the hallmark properties of stem cells in the...
by Katy Spink, Ph.D., Dark Horse Consulting Group’s COO & MP Katy Spink Presents at an Internal DHC Retreat in 2018 Full disclosure: my CGT career began just over 20 years ago when I worked with pluripotent stem cells at Geron . I’ve always been a believer in the...
by Dr. Steve Oh, PhD Independent Cell Therapy Leader Singapore A webinar presented by the ISCT Process Development and Manufacturing (PDM) Committee Particulates are everywhere but do they pose a problem in cell and gene therapy products? On the 16 Oct. the...
ISCT’s Process Development & Manufacturing Committee invites you to take part in a survey to determine the current state of Process Analytical Technologies (PAT) in Cell & Gene Therapy (C>) Manufacturing. Fundamental analytical challenges exist when manipulating and expanding...
Sponsored content provided by Stemcell Technologies ISCT Industry Member Human pluripotent stem cells (hPSCs) can be a powerful tool in your cell and gene therapy development toolkit. However, most clinical applications require many more hPSCs than can be generated in a...
William Watt, PhD President, Astellas Venture Management LLC Please introduce yourself. What is your background and experience in cell and gene therapy? My basic training was as a scientist, I earned a PhD in Pharmacology from the University of Washington and carried out 3...
by Shannon Eaker, PhD, Chief Technology Officer at Xcell Biosciences * Dominic Clarke, PhD, Consultant & Chief Strategy Officer at Orange County Bio * *Representing the International Society for Cell & Gene Therapy (ISCT) Process Development and Manufacturing (PDM)...
Miltenyi Bioindustry is a global CDMO service provider specializing in cell and gene therapy. With more than 25 years of experience, we offer comprehensive process development and manufacturing services for both autologous and allogeneic cell therapy programs. We provide high-quality lentiviral...