Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal requirements. This is challenging because the products and their development and manufacturing processes differ from traditional models, as Elena Meurer, Principal Consultant and CMC expert at Biopharma Excellence, explains.
NOVEL AND ADVANCED therapies are coming under increasing focus in the pharma sector. Ten or 15 years ago, most of these products were only just entering the early clinical research stage. Now, however, the market is more evolved and there is a shift towards later clinical trials as various cell and gene therapies enter the later stages of development. Indeed, we already have a number of approved therapies.
There are several examples of approved chimeric antigen receptor (CAR)-T therapies; and CRISPR technologies and induced pluripotent stem cell (iPSC) therapies have made substantial progress too. Simultaneously, new players are coming in and new types of products emerging, including the three‑dimensional (3D) printing of organs and products for ‘bedside manufacturing’.
All of these developments are enormously positive of course, but they also mean that the bar is being lifted in terms of the formal requirements for manufacturing process consistency, good manufacturing practice (GMP) standards and so on. This is the natural course of things as the knowledge base grows. Yet it also presents some challenges.
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