Five minutes at CPhI worldwide with …  

Jean Bléhaut – President, Synthesis EU

CO/PH: As a CDMO there is more and more a trend towards integrated pipelines. Do you follow this?

Jean Bléhaut: We definitely look at integration where it makes sense. For example, in the case of an ADC, which involves the attachment of a cytotoxic small molecule (the ‘payload’) to an antibody, you have to manufacture the payload, the antibody, and a linker. And then you have to put them together. Novasep has been involved for many years inpayloa and linker manufacturing, and we are also now starting to offer the conjugation service. We opened a 11 million Euro facility for bioconjugation at Novasep’s Le Mans, France, site, which specializes in highly potent APIs for cancer treatment. At the same time we are involved in monoclonal antibody manufacturing, for targeted therapies and orphan drugs, typically using up to 1000 liters bioreactors. And yes, this trend towards integration is true also for other biomanufacturing -such as production of viral vectors for therapeutic vaccines and gene therapy. We are also investing in our fill & finish capabilities to get to the drug products.

CO/PH: What variety of antibodies you offer?

JB: We are surely not limited to a single type of antibody. We have a partnership with another French company, GTP, involved in the early development and non-GMP scale up. Novasep takes care of the final scale up. Thanks to them we do not have limitations on the portfolio of antibodies at our disposal.

CO/PH: What Payload/linker  technologies you offer for ADC?

JB: We have experience with a number of different technologies, including maytansins, auristatins and PBDs, to name a few. We do not have proprietary technologies we are specialized on, we can offer a broad range of chemistries.

CO/PH: What applications are most requested in biologicals?

JB: Mostly oncology, for example ADCs. We have been involved in bioconjugation projects for other applications, however. Speaking of viral vectors, I cannot disclose too much but we have projects with indication for ocular medicine, systemic disease, some gene therapies and some other therapeutic vaccines. Being a CDMO, the approach is the same that we have with, say, small molecule APIs or intermediates: take the technology of our customer and scale up from laboratory scale to production scale. We work with lentivectors, adenoviral vectors, AAV and others, and we are capable of scaling up vectors of all types, regardless of the application. As proof of our commitment, we recently launched a 27 million Euro investment in a commercial manufacturing plant of viral vectors in Charleroi, Belgium. It is a site that we acquired in 2009 and it is now specialized in this biomanufacturing.

CO/PH: Apart from biologicals, what are your strong technological capabilities?

JB: The largest part of our activites is still small molecule CDMO. We have several cGMP production sites and we produce demanding APIs and advanced intermediates. We have a site dedicated for example to large-scale hazardous high-energy chemistry such as azide or nitration chemistry. We are strong in low temperature chemistry: we announced this morning a 4 million Euro expansion in cryogenics capabilities. Historically we have a long tradition of very large scale chromatography purification, and we sell chromatography techniques and equipment to the industry. We use them to separate everything, from ADCs to racemic mixtures at the hundreds of tons scale, omega-3 compounds purification and so on. I am a strong believer however that we should not forget the more conventional chemical synthesis capabilities. As a Western CDMO we can offer proximity, competency and while we boast some unique technological capabilities, classical organic chemistry synthesis is still our bread and butter.

CO/PH: Do you employ flow chemistry?

JB: We do flow chemistry at the R&D scale but it is something that our researchers are looking forward to put into production.

CO/PH: Your impression from CPhI 2017?

JB: CPhI is really a must to attend. It is always a great opportunity for us to meet our customers, and for us it is the largest event we participate every year. And this year is set to be a good edition.