The 10,000 sq ft plant will produce non-sterile supplies for early phase trials and has the capacity to handle pharmaceutical powders, ointments and creams, as well as oral and topical liquids.
The unit will also provide trial-specific services including over-encapsulation, used to ensure that studies are conducted in controlled conditions, and a range of trial pack manufacturing options.
Velesco COO Gerry Cox told Outsourcing-pharma.com that the idea behind the new facility is to create “a ‘one-stop shop’ for our clients in need of the formulation, analytical and clinical supplies support required to move from preclinical to the clinic.”
He added that: “Velesco's goal is to provide the formulation and analytical services along with the clinical supplies needed by our clients to achieve the "proof of concept in humans" milestone.”
Cox was also confident about the level of demand for trial supply manufacture despite the higher project cancellation rates reported by some contract research organisations (CRO) in the last few months.
“The global economic downturn has certainly had an impact on the industry but Velesco's business continues to grow. We are a young company and we are focused on controlling our cost structure as we move through the current downturn.”
This assertion fits with comments made by CROs like Covance and Charles River Laboratories which also focus on the preclinical and early trial market. Both have recently predicted that the decline in demand for such services is beginning to recover.
Michigan CMC Alliance
Velesco has also moved its analytical and formulation laboratory from Ann Arbor to a larger facility in Plymouth, Michigan that was previously owned by global drug giant Pfizer.
The laboratory expansion and the new trial manufacturing facility are sure to be welcomed by the other members of the Michigan CMC Alliance, which Velesco joined in April.
The group allows Velesco and other contract services firms like Ash Stevens, BioSTAT Consultants, PharmaMed and ProReg to pool resources and provide a broader range of services.
Another factor likely to have influenced Velesco’s expansion is its receipt of a high tech mega tax credit from the Michigan Economic Growth authority which, the firm said, will significantly enhance its operational capabilities.