Firms’ expanded alliance allows use of German partner’s stationary phases for taxanes.
Novasep and instrAction have broadened their existing API purification technology alliance to cover taxane drugs. Novasep says the extended collaboration means it will be able to develop and operate or supply optimized large-scale chromatography processes for the purification of taxane-based APIs and intermediates, utilizing instrAction’s stationary phases. The firms inked their original alliance covering nonchiral chromatography in July 2010.
Germany-based instrAction develops and manufactures “Instruction® Receptor Phases” as novel API-selective resins for chromatography. It claims the Instruction technology enables the immobilization of a wide variety of functional ligands on a polymer network coated on very different porous backbone materials. The overall platform allows small molecules as well as high molecular weight molecules to be separated by highly selective reversible interactions. The firm has synthesized a family of selective stationary phases that it claims demonstrates strong potential for the purification of various taxanes.
The latest agreement means Novasep will be able to access instrAction’s technology to develop a multistep synthesis or semi-synthesis, and optimize purification steps using its partner’s set of taxane-selective chromatography stationary phases. The resulting optimized process can then be scaled up for clinical and commercial-scale purification. Alternatively, Novasep notes, it can supply the process to its customers, as a combination of its own Prochrom® HPLC columns and systems, with instrAction’s selective stationary phases.
“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,” comments René De Vaumas executive vp for business development at Novasep Synthesis.
Novasep develops and manufactures taxane-based APIs and intermediates at its FDA-inspected, SafeBridge-certified site at Le Mans in France.