California based IT and professional services firm PSC said it would set up BioTechnique last week, explaining that the contractor will be based at a site in Madison, Wisconsin recently acquired from the Morgridge Institute for Research.
The 37,000 square foot facility at Madison University’s Research Park was built by Mentor Biologics in 2008, which intended to use the facility to make a botulin-toxin product, PurTox in a bid to capture market share from Botox.
This plan was shelved in 2010 after Mentor was bought by US drug giant Johnson and Johnson, which decided it could make PurTox using existing capacity. The facility – worth an estimated $16m – was subsequently donated to the Morgridge Institute.
Raphi Hanessian, managing director of PSC Biotech’s investment wing, said the facility will “help meet the high demand for cytotoxic and high potency fill-finish contract manufacturing services of sterile injectable products.”
According to PSC, BioTechnique will provide the pharmaceutical industry with specialized filling services for cytotoxic, high potency, biologic, and other sterile injectable drugs when fully operation in 2015.
Injectables trends
US sterile injectables capacity has been struggling to meet demand since Ben Venue first halted and then abandoned manufacturing operations in 2011 after a number of quality problems at its site in Ohio.
The failure of Ben Venue – recently sold to Hikma by Boehringer Ingelheim – resulted in drug shortages, notably of J&J’s ovarian cancer treatment Doxil, and prompted law changes on both sides of the Atlantic requiring drugmakers to report potential supply disruptions.
In the years since the a number of firms in the contract manufacturing sector have invested in sterile injectables manufacturing capacity with – before Hikma – DPT and AMRI being the most recent examples.
The fallout of the Ben Venue problems has also seen some manufacturers decide to take production back in-house, examples of which include Pfizer and Sun pharma which recently acquired InnoPharma and Pharmalucence, respectively.