Monday, 7 February 2011

Novasep and instrAction expand alliance to include taxane purification

Novasep, a supplier of manufacturing solutions to the life science industries, and instrAction, a manufacturer of innovative chromatographic stationary phases for API purification processes, today announced they have expanded their worldwide strategic alliance to include the purification of taxanes, a well-known class of anti-cancer compounds.

This extended collaboration enables Novasep to develop and operate or supply optimized large-scale chromatography processes for cost-effective purification of taxane-based active pharmaceutical ingredients (APIs) and intermediates. The two companies announced a strategic alliance covering non-chiral chromatography in July 2010. The extended relationship means Novasep adds enhanced taxane anti-cancer compound capabilities to its extensive range of manufacturing solutions for life science industries.

Novasep customers will benefit from the collaboration as they will be able to access a cost-effective one-step purification solution for their taxane-based APIs. A large number of clinical trials involve paclitaxel and docetaxel, two of the leading anti-cancer APIs marketed today, and approved for the treatment of breast, ovarian, prostate, non small cell lung cancers, etc., and also new taxanes, taxane conjugates or combinations between taxanes and other APIs.

instrAction has synthesized a family of API-selective stationary phases among their 3,000-phase library based on its proprietary technology, which have shown a strong potential for the purification of various taxanes. Access to instrAction’s technology means Novasep can develop a multi-step synthesis or semi-synthesis, and optimize purification steps using instrAction's set of taxane-selective chromatographic stationary phases. Novasep can then scale up the optimized process and produce the API for clinical and commercial purposes. Alternatively, Novasep can supply the developed process to its customers with performance guarantees, integrating Novasep’s leading Prochrom(R) HPLC columns and systems and instrAction’s selective stationary phases. For mature or generic APIs, Novasep and instrAction can additionally file and license application patents to extend the protection of their customers’ products.

Novasep develops and manufactures its customers’ taxane-based APIs and advanced intermediates at its FDA inspected and SafeBridge certified Le Mans site in France, specialized in highly potent API (HPAPI) synthesis and purification.

“Thanks to instrAction’s highly selective chromatographic stationary phases and Novasep’s 20 years experience in taxane synthesis and purification, we are looking to see a paradigm shift in solutions for our customers worldwide as a result of this collaboration,” says René De Vaumas, executive vice president in charge of Novasep Synthesis’ business development.

“We are delighted about our extended collaboration with Novasep, a leader in taxane synthesis and purification,” said Dr. Thomas Schwarz, CEO of instrAction GmbH. “The cooperation with Novasep in the field of taxane purification is a further important milestone to implement the instrAction technology in industrial downstream processes. We are very confident that it will be broadly applied to the industrial purification of APIs in the future.”