The expanded lab will house a range of reactors capable of supporting low-temperature – cryogenic – reactions. It will also be a regional base for Novasep’s chemistry and purification business, including its chromatography and evaporation offering.
In addition, the lab will also be equipped with analytical tools for process R&D, including process safety testing capabilities.
Novasep said the expansion will be completed in the next few months and predicted that production will begin in May.
The privately-owned French contract manufacturer did not give financial details of the Boothwyn investment but did say it was a direct response to demand from US customers.
Thierry van Nieuwenhove, president of Novasep’s synthesis business, told us “For many years, Novasep has been offering purification development services from our US facility, based on specialized technologies.
“Customers appreciate the locally based engineers working in close proximity with them to carry out technical transfer, provide development & the scale-up of services and then accompanying them through the transfer to our FDA inspected manufacturing assets in Europe.”
Novasep’s US customer base was reduced by the sale of Pharmachem in 2014.
The divested unit, which was bought by Novasep in 2007, produces the API tenofovir disoproxil for Gilead’s HIV and hepatitis B treatment Viread at its facility in the Bahamas.
According to a Moody’s note Pharmachem generated 40% of Novasep’s earnings in 2014, which the rating agency said “depends upon one single active ingredient, Tenofovir, which is sold to a single customer.”
More recently, Novasep lost Celladon as a customer.
Last March the San Diego, California biotech contracted Novasep to supply the active pharmaceutical ingredients (APIs) for its gene therapy heart disease drug Mydicar (AAV1/SERCA2a).
However, Celladon cancelled the contract – and a larger deal it had with Lonza – a few months later after Mydicar failed to meet primary or secondary endpoints in a Phase IIb trial.
Nieuwenhove told us “US sales have always been a very important part of our strategy and turnover. The sale of the Pharmachem site was part of our ‘Back to Basics¹ strategy aiming at refocusing Novasep's activities on core businesses.
“Even without Pharmachem, our presence in the US has remained important. Novasep has built many relationships over the years there and this investment is a step further in the strengthening of our established and future relationship with US-based pharmaceutical companies.”