French firm Novasep has significantly boosted its ability to provide customers with enantiomerically pure compounds with the addition of a new chiral chromatography unit.
The contract manufacturing firm has added a state-of the art cGMP (current Good Manufacturing Practice) continuous chiral chromatography unit to its facility in Chasse sur Rhone, France.
According to the company, the new chromatography unit will be able to provide customers with “cost efficient separations of kilograms to tens of kilograms of pure enantiomers for clinical supplies.”
The term chiral is used to describe an object or molecule that cannot be superimposed on its mirror image, with the two objects being referred to as enantiomers.
The pharmacological activity of two enantiomers can vary dramatically, with one showing activity towards the target of choice, while the other will either be inactive or, even worse, toxic.
As such, the importance of obtaining enantiomerically pure chiral molecules is hard to overestimate, with over 50 per cent of all drug compounds containing at least one chiral centre.
The company currently operates six FDA-inspected facilities that manufacture active pharmaceutical ingredients (APIs) advanced intermediates with four of them now offering integrated chiral separation services.
“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,” said René de Vaumas, Vice-President Exclusive Synthesis at Novasep.
“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. "
Novasep now has ten pilot and commercial scale HPLC (high performance liquid chromatography) units as well as eight pilot and commercial scale Varicol continuous chromatography systems that can produce batches of up to 1 metric ton with a total capacity of more than 150 metric tons a year
At the start of the year, Novasep announced that it had installed an €8m high potency active pharmaceutical ingredient (HPAPI) plant at its facility in Le Mans, France as part of a €50m investment scheme.