POMPEY, France, September 26 /PRNewswire/ --
- Custom Chiral Separation Using Preparative Chromatography Eases and Speeds up Process Development; Rapidly and Efficiently Producing the Required Amount of Compounds for Early Development Phases While Being Cost Efficient at Industrial Scale
Novasep, a global leader in advanced separation technologies, has recently added a state-of-the-art cGMP pilot scale continuous chromatography unit in its Chasse sur Rhône (France) facility. This ensures cost efficient separations of kilograms to tens of kilograms of pure enantiomer for clinical supplies.
Today, Novasep operates six FDA-inspected facilities that manufacture APIs and advanced intermediates. Four of them integrate chiral separation services from preclinical to commercial supply. Novasep now operates ten pilot and commercial scale HPLC units, eight pilot and commercial scale Varicol(R) systems (continuous chromatography systems) for producing batches up to 1 metric ton with a total capacity of more than 150 metric tons per annum.
This investment expands Novasep's chiral separation capabilities. The fully operational plant includes a Varicol(R) 8-80 unit, using 5 to 8 columns of 80mm i.d. and incorporates the latest PAT-compliant advanced control technology.
"Novasep, the world leader in preparative chromatography and the pioneer in continuous chromatography, was equipped with multiple HPLC and Varicol(R) systems." commented René de Vaumas, Vice-President Exclusive Synthesis. "With this new investment we are filling a gap in our service offerings. We are now extremely competitive for producing clinical batches of chiral compounds quality wise, time wise and cost wise."
René de Vaumas added "This addition follows our recent investments in three cGMP multi-step synthesis kilo-labs. Our customers will benefit from Novasep's continued commitment to improve and adapt its custom manufacturing capabilities to their evolving needs. "
About Novasep's Varicol(R) 8-80
Novasep's new Varicol(R) 8-80 is a compact industrial continuous chromatography system. It only requires 2 to 3 kgs of CSP (Chiral Stationary Phase) to produce up to 100 kgs of desired enantiomer in a few weeks. It incorporates full solvent recycling, and ensures straightforward scale-up to industrial units for late stage and commercial production. The Advanced Control System (ACS) ensures automatic control to enable users to get quantitative pure product recovery, and to maximise productivity with optimum process robustness.
About Novasep
Novasep is a leading partner for the Life Science industries and provides true performance solutions.
Novasep supplies process development services, process equipment and systems, custom synthesis and purification services, and active complex molecules (reagents, building blocks, generic APIs).
Novasep' s solutions provide robust, efficient and economical benefits to produce pure complex molecules and apply to:
- Synthetic molecules, combining conventional technologies with special chemistry (hazardous chemistry, chiral technology, HPAI handling, multi-ton manufacturing, chromatography, etc.)
- Biomolecules, using optimized purification technologies (unit operation or complete downstream processing from fermentation, cell culture or plant to final polishing, including membrane processes, chromatography, etc.
Novasep constantly innovates to resolve customers' challenges in obtaining pure complex molecules.
As user of its own technologies, Novasep understands customers' challenges and shares its experience and know-how to provide them with the best solution.
Contacts : Jean-Marc Le Rudulier at +33-(0)6-87-69-06-57 or jean-marc.le.rudulier@novasep.com http://www.novasep.com
Contacts : Jean-Marc Le Rudulier at +33-(0)6-87-69-06-57 or jean-marc.le.rudulier@novasep.com
Comments