Security Of Supply In Cell And Gene Therapy Manufacturing

In the biopharmaceutical industry’s long-standing battle against cancer, CAR T cell therapies have proven to be an effective tool to treat the global killer. Recognition across the industry of their potential has driven many companies to invest R&D efforts into bringing cell and gene therapies to market, which has led to over 1,000 of these drugs in today’s development pipeline.¹ This accelerated interest has come primarily off the back of the phenomenal clinical efficacy of the two approved CAR T cell therapies on the market, Kite/Gilead’s Yescarta and Novartis’ Kymriah. Over 80 percent of lymphoma patients who received Yescarta or Kymriah have seen either a significant reduction in the extent of their cancer or have gone into remission.²

However, major challenges in manufacturing cell and gene therapy products were not addressed, including a lack of automation, outdated analytics, and an immature supply chain with the first approved cell therapies accelerated path to the market. The latter is especially concerning, due to the vast difference between the patient impact of a supply chain interruption for a traditional biologic versus a cell and gene therapy. For example, although a batch of a traditional biologic medicines lost to errors or contamination typically can be costly, it often does not create a major interruption in supply. Pharmacies still have drugs in stock, and the manufacturer is able to manufacture another batch in its place. While the drug company faces lost costs and resources, the patient rarely sees an impact in terms of access to the drug they need. With cell and gene therapy, though, each batch is produced for one patient. If something happens to it during manufacturing, the patient impact could be as serious as death.

Therefore, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs. Cytiva realized the importance and urgency of this need and implemented a Security of supply program, including business continuity and supplier risk management initiatives to better understand and reduce supply base risks, thereby ensuring therapy availability for their customers’ patients.