Author Archives: David James

Small–Batch-Size Production

    After coexisting as close cousins in the world of life sciences, the bioprocessing and cell therapy industries now find themselves as possible allies in the pursuit of solutions to small–batch-size production technology. As cell culture titers continue to increase and biotherapies become more “personalized,” pressure is increasing on the bioprocessing industry to find more cost-effective and flexible technologies for producing smaller batch sizes than before. At the same time, the cell therapy industry (renowned for its small–batch-size production)…

Therapies of Tomorrow Require More Than Factories from the Past

Live cells are being incorporated as active agents and delivery vehicles for a broad range of emerging therapeutic strategies. Successful commercialization of a cell therapy requires more than proving its safety and efficacy to regulators. Ultimately a therapy must be commercially viable, allowing enough patients to be treated with an adequate financial margin to justify investment in it as a product. “Whether the cells used are universal (allogeneic) or patient-specific (autologous), it is unlikely to be wholly one or the…