Five minutes with…
Didier Combis, Director B.U. Exclusive Synthesis & Pharma Chemicals, PCAS
Chemistry Today: What parts of the market are driving growth for PCAS?
Combis: I cannot speak for the other business units which are also doing well, but clearly the pharma segment is extremely important and is a major growth driver for PCAS. In the past two years most of our growth came from custom manufacturing of pharma chemicals, APIs and GMP intermediates. In December 2016 we acquired from Covance a major development center, east of Paris, that was originally built by Sanofi. This is a fantastic opportunity for us, since we wanted to find a large and first class facility to concentrate all our API development capabilities in one place -and this former Sanofi-Covance facility is next door to one of our API sites in west Paris. It can host up to 200 scientists and will boost our capabilities for clinical development projects.
CT: Impressive. Does it work according to GMP?
Combis: It is working according to cGMP, but our intent is to use it mostly as a development site, more than a commercial manufacturing site. PCAS operates however seven commercial production sites: four of them for GMP manufacturing, three instead devoted to regulatory starting materials. We see that the complexity of molecules is increasing and thus the non-cGMP steps, the regulatory starting materials are very critical now for quality, supply chain security and cost control of the APIs.
CT: What are your technological highlights?
Combis: We are mainly driven by our technological capabilities. Besides cryogenic chemistry , complex heterocycles, hydrogenation or c-c coupling, Biocatalysis is a very important area for us. We operate a dedicated biocatalysis research center located south of France. We have a whole team of scientists experts in protein science and microbiology ,and we are back-integrated with a library of extremophilic microorganisms providing unique DNA strains. Thanks to our partnership with the French Research Institute for Exploration of the Sea (IFREMER). From there or other microorganisms coming from various places in the world , we generate mutants and screen them to find new biocatalysts specific for a given reaction and substrate. Scale up is then possible, both in-house and externally if needed. This really brings value to our customers looking for cleaner, patentable and cost effective processes.
Finally, PCAS is building a solid state / crystallization R&D group in 2017 to support our customers at the frontier between Drug Substance and Drug Product.
CT: And about flow chemistry?
Combis: So far we cannot support flow chemistry for very large development projects. We have industrialized only two projects based on flow. But it is definitely a direction we are taking. I cannot disclose details now, so let’s just say that this is going to change and actions are taken to become more attractive in that field.
CT: What does PCAS offer that no one else can?
Combis: A real one-stop shop for drug substances, from development / clinical phase to commercial maturity. I like to say that PCAS is well equipped to manage complexity and is focused on drug substances and the associated CMC challenges. We are a long term partner for our customers, and we are positioned as a true global CDMO to follow the whole API cycle from phase I-early phase II up to launch and commercial production . We have strong R&D capabilities, very strong analytical support for the development phase supporting methodologies like Quality by Design, and we are capable of meeting the higher and higher demands from agencies.
PCAS is not going after all directions like formulation of drug products but is focused in getting better and better to support emerging and large pharma for their DS development and manufacturing.
