According to Andrew Brennan, general manager at Novasep’s US operations, Novasep will be able to offer US drug developers preclinical scales of “any fine chemicals whether they are advanced intermediates or active ingredients” from the newly completed synthesis laboratory and kilo lab at the Boothwyn, Pennsylvania site.
“We use chemistry in this lab as upstream, combined with purification downstream steps,” Brennan told in-Pharmatechnologist.com.
“The facility is equipped with jacketed reactors ranging from 100mL to 50L in size and with a 35L filter dryer for isolation of kilogram quantities of compound.”
The privately owned French manufacturing services provider said the expansion is part of its 'back to basics' strategic plan, bringing more localised development services to the US pharma market, and would also serve as a regional base for Novasep’s complete portfolio of preparative chromatography technologies.
The project was first announced in January, and is a boost for the firm’s North American presence which has been hit by Celladon ending a contract last year, as well as through Novasep’s divestment of Pharmachem in 2014.
The unit had been acquired by Novasep in 2007, and was responsible at one time of generating around 40% of Novasep’s earnings through the supply of the active ingredient Tenofovir, sold to a single customer.
But with the expansion, Brennan said: “We are already speaking with customers on specific projects for the production of first kgs of early stage drug substance.”