Author Archives: David Smith

Advancing Robust Manufacture of T-Cell Therapies: Application of Single-Use Stir-Tank Bioreactors

by , and

With the increase of T-cell immunotherapy research, cell therapy developers have encountered the difficulty of producing consistent, high-quality products. Approved therapies Kymriah™ (tisagenlecleucel, Novartis), Yescarta™ (axicabtagene ciloleucel, Kite Pharma), and late-phase clinical products BB2121 and UCART19 have been critiqued for presenting potential obstacles to patient access because of high costs of treatment and variable manufacturing outcomes. Manufacturing processes need to be developed to increase control over each unit step in a way that improves product consistency over the life of…

August 4, 2019

Demonstrating Scalable T-Cell Expansion in Stirred-Tank Bioreactors

by , , , and

Emerging cell therapies have excited the pharmaceutical industry because they indicate potential new pathways to treat some of the most life-threatening diseases. T-cell therapies currently are the flagship technology in cell therapy with recent US FDA approvals of Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) treatments. Those therapies and others still in development use peripheral blood isolated lymphocytes (PBLs) modified with chimeric antigen receptors (CARs) or modified T-cell receptors (TCRs) to trigger the innate cytotoxic response of these immune…

June 23, 2018

Clinical/Commercial Manufacturing: BPI Theater @ BIO 2015

by , , , and

Tony Hitchcock (technical director, Cobra Biologics) 1:30–1:55 pm The Expanding DNA and Gene Therapy Market The gene therapy market has fluctuated dramatically over the past 20 years. But Hitchcock noted that over the past three years there has been a huge emergence of successful clinical outputs of gene therapy, with a large number of IPOs and significant funding. Even more interesting is the number of large pharmaceutical companies bringing gene therapy into their portfolios. Hitchcock pointed out that it is…

August 24, 2015