Cell therapy demand means CMOs need to up their capabilities, PharmSource
Industry will converge on The Javits Center in New York City next week to discover the latest technologies and movements within the biopharma manufacturing space.
According to Fiona Barry, the new editor of PharmSource – a GlobalData product – on of the most hotly anticipated topics at this year’s show will be cell therapies, driven by the approvals of Novartis’ Kymriah (tisagenlecleucel) and Kite/Gilead’s Yescarta last year.
This is creating demand for contract manufacturing organisations (CMOs) which will need to fill gaps in their capabilities, especially for autologous therapies, Barry told Biopharma-Reporter.
“Manufacturing capabilities needed for autologous cell therapies are not yet common, and most CMOs are not yet competent,” she said. “Our research shows there only approximately 30 companies involved in contract manufacturing autologous cell and tissue therapies.”
There has been some action by CMOs to increase their cell therapy offering over the past year. Swiss manufacturer Lonza acquired PharmaCell in June, for example, but most manufacturing, for now, is being done in-house.
Therefore CMOs need to build competency in a range of services to support reproducible production methods for autologous cell therapie, said Barry, including “growing human cells, assays, automation, and even in filling the skills gap among staff.”
Furthermore, there is a growing opportunity for other service areas to help support this growing space.
“Supply chain logistics are more important than ever for these therapies, because they represent the patient’s own irreplaceable cells and are often a last resort treatment,” Barry added. “Quality testing is also crucial for this vulnerable population.”
