Speaking to Outsourcing-Pharma.com at this year's Interphex trade show, a spokesperson from the company's cytotoxic services division said that in response to customer demand, the firm has spent the last year and a half upfitting an area of its plant in Greenville, North Carolina, to build in this new capability.
Specifically the company can complete the fill and finish of aseptic liquid and lyophilised drug products, in an assortment of vial sizes up to 65ml.
The plant can conduct small scale and biologic manufacturing.
The facility uses air sync barrier technology, has aseptic class 100 clean rooms, and within the filling room it uses a restricted access barrier system (RABS).
The pharma industry has seen a biotechnology revolution in the past few years and it is estimated that biologics now make up 13 per cent of the total prescription drug sales in the US.
Moreover, with currently more than 400 biologic products in clinical trials and approximately 700 biologics products in preclinical or early stage development, there is a growing thirst for contract manufacturers that can support specialised biomanufacturing processes on a commercial scale, with cytotoxic and aseptic capabilities an important feature, as this is what many of the next-generation anti-cancer and high potentcy therapies require.
" We have had a lot of enquiries already from potential clients as there is a real need for this service in the marketplace - hardly anyone has the capability - it's a tricky and expensive process to master, as cytotoxic manufacturing requires the creation of a separated and sterile area and the return on investment for companies to create this in-house is not good ," said the spokesperson.
Until now, the only other contract manufacturer offering commercial scale cytotoxic manufacturing in the US was Ben Vienue, who has been doing so for many years, another company spokesperson said.
" We are in good standing with the regulatory agencies in regards to compliance ," they said.
The company has already signed up a couple of products to be made at its new facility, according to the spokesperson.
Meanwhile, in as well as the FDA, DSM's new facility has also been inspected by the European Medicines Agency (EMEA) and the firm has already received some requests from potential customers in Europe because of its biologic capability, the spokesperson said.