When we look at the current trends with what we can refer to as “next generation therapeutics”, whether it be ADCs or cell and gene therapy products, one trend is very clear, products are becoming increasingly complex in their nature. Certainly, the complexity of the manufacturing processes used to produce them clearly reflects this; hand in hand with ever increasing product development costs and timelines.
Many of these products are being developed by small start-up companies frequently funded through long term partnerships with large pharma. However, when it comes to the manufacturing, it is pretty much assumed that this will be outsourced to a Contract Development and Manufacturing Organisation (CDMO). There is an unwritten assumption within this that the CMO will have established processes, capital equipment and skill base even for highly novel therapies and that these services can be provided on a readily available “fee for service” basis, going to the lowest cost provider. Such an approach may work for processes with established manufacturing platforms, but does it hold for new and emerging therapeutics?
The translation of the “next generation therapeutics” into affordable marketed therapies is going to require a significant amount of enterprise and I think a different manufacturing approach is going to be required. The development of manufacturing processes that are suitable for in market requirements in terms of quality, scale, cost and compliance is a substantial hurdle whatever the products. For the next generation, such as viral vectors, there are many snags not least with the highly complex supply; including the use of biological starting materials such as plasmid DNA or RNA which in themselves are produced from complex biological processes. The viral vectors may themselves be used to generate modified T-cells in ex-vivo therapy models which represent a step change in the level of complexity for manufacturing and supply chain management for the drug developer.
For late phase and in-market supply CMOs will need to make significant investments in terms of process, analytical and skills development as well as the capital investment for a product area where in reality there are currently very few licenced products. To heap more on to this ever bourgeoning stack for drug developers control and security of the supply chain are now becoming major concerns, on top of those relating to cost and affordability of their products.
I would therefore suggest that a different kind of relationship between drug developers and manufacturers is required to overcome these hurdles; one of long term collaboration and shared risk is required where the required manufacturing technologies and capabilities and skill sets are established. Going forward, security of supply in the first instance is going to depend upon having robust and scalable manufacturing processes which allow for material supply for late phase clinical development and in-market supplies. Achieving this will need CMOs and drug developers to work together to realise these shared and ambitious goals.