US-based drug discovery services specialist Nanosyn is extending its activities to the production of active pharmaceutical ingredients (APIs) for preclinical and clinical trials through a joint venture with French company PCAS.
For the French partner, which provides commercial-scale pharmaceutical synthesis and fine and speciality chemical manufacturing services to clients worldwide, the tie-up is an “ideal next step” in continuing to expand its North American customer base that allows the company to “place critical preclinical and clinical trial API synthetic capabilities nearer to our clients in the US”.
Nanosyn and PCAS have signed a joint-venture agreement to run PCAS-NANOSYN, LLC, a current Good Manufacturing Practice (cGMP)-standard kilolab in Santa Rosa, Northern California. Dr Olga Issakova, executive vice president of Naprosyn, has been appointed chief executive office of the joint-venture company.
PCAS-NANOSYN will operate out of an already fully functioning site acquired by Nanosyn with the physical assets of Seres Laboratories last March. Part of the joint-venture strategy is to expand the site (Nanosyn retained the existing staff) by upgrading its research and development and analytical capabilities, while adding new, advanced capacities.
At the moment, the Santa Rosa facility houses six GMP suites, two of which are certified as Class 10,000 clean rooms. The joint venture’s customers will further benefit from “the significant chemical and analytical resources within the parent companies, and the ability to seamlessly transfer projects for larger scale to PCAS’ network of four FDA [US Food and drug Administration]-inspected pilot and commercial-scale plants in Europe”, the partners noted.
Nikolai Sepetov, president and chief executive officer of Nanosyn, said the joint venture was “a natural extension” of the company’s “highly successful discovery services into process development, scale-up, and supply of preclinical and cGMP clinical trial quantities of APIs”.
