By Patrick Stragier, General Manager, Catalent
Unlike traditional biologics, where the industry has standardized productivity and process efficiencies, the cell therapy landscape is laden with nascent processes and constant technical innovation. This growing market is expected to reach $48.11 billion by 2027.1 Proving efficacy and safety remains a priority, but the specificities of cell therapy ― scale-up of individualized therapies, chain of custody management, and complex manufacturing processes across multiple modalities ― have created specialized challenges in their path to market, with fast-track designations increasing the pressure on biopharma companies to move quickly.
Many manufacturing partners have a wealth of experience scaling up traditional biologics with market-proven licensable technologies at their disposal. With both process scaling and technology applications still developing across the wide range of cell therapies, the role of manufacturing organizations becomes even more crucial than relying on in-house manufacturing to move the cell therapy to clinic. With limited standardization elements in an emerging market such as cell therapy, innovators could benefit from working with an expert manufacturing partner that has broad expertise, infrastructure, and a history of customer programs under their belt to leverage from and bring the necessary process efficiencies at scale.