In an exclusive interview, Hugues Bultot, Chief Executive Officer of MaSTherCell, an emerging pioneer in the industrialization of cell-based therapeutics, based in Gosselies (Belgium) shares with us his vision for the future of the contract manufacturing organization (CMO).
The cell therapy sector is growing fast in Wallonia, how far will it go?
Hugues Bultot: "Cell therapy has literally exploded in Wallonia over the past 5 years. At that time, Walloon companies were starting to focus on regenerative medicine while, in the USA, cell therapy companies were already tackling immunotherapy for example. In a recent interview, Christian Homsy (CEO of Celyad – ex. Cardio 3 BioSciences) said that the Walloon cell therapy sector needs to broaden its horizons and I agree with him. Today we have to be very accurate when it comes to cell therapy since it covers many different segments such as regenerative medicine, ex-vivo gene therapy, or immunotherapy."
How will your CMO broaden its horizons?
Hugues Bultot: "It is recognized that many therapies that are developed today will not be sustainable in the long run because they are too expensive. Cell therapy companies’ margins are under pressure because of high cell processing costs. Because it is also subjected to a high market pressure, the cell therapy industry is more than ever paying attention to the manufacturing key elements. Their CMO partner is one of them. Yet, CMOs’ profile is changing and is no longer only about manufacturing. CMOs must now offer innovative processing solutions (such as automation, lean manufacturing, efficient SOPs) and deal with quality control or regulatory affairs. These are the new horizons for our company and they will create much more value than with “basic” manufacturing, even if they imply new skills that we have not necessarily acquired yet! We expect that the importance of revenues coming from strict clinical batches production will lose in importance in comparison with these other activities."
We have to become a “one-stop-shop” partner with a fully integrated vision, from clinical trials support to commercialization.
What will your international strategy rely on?
Hugues Bultot: "Geographical proximity and local regulatory standards are some of the criteria that will shape our international strategy. It is important to mention that, regulatory standards differ from a country to another. The idea is to give companies the opportunity to find solutions to develop their products in accordance with applicable standards. This is as true for small European companies that need to go abroad to reach the next step of their clinical development, as it is for international companies that are knocking on Europe’s doors to overcome local blocking standards. Logistics networks are also key and will clearly determine the geographic areas where we will establish our production units. Playing local will allow us to quickly respond to our clients’ needs and to help them solve therapeutic side issues."
What is the next challenge of the cell therapy industry?
Hugues Bultot: "The next challenge will be about bioprocesses (equipment, automation, efficient quality control, optimized workflow etc.). Value creation will emerge from reduced costs but also from induced jobs as well as a very specific know-how in that field. Companies will look for new profiles specialized in cost modelling, GMP workshop management, etc. These profiles already exist in big pharmas such as GSK. Yet, as long as start-ups and SMEs do not succeed in increasing their margins and as long as they do not have the vision of what clinical trials or their products commercialization will imply in the long run, their ambitions and their development will be limited."