The US contract manufacturing organisation (CMO) has installed a pilot-scale Anhydro spray dryer and tableting and encapsulation technologies at its plant in Bend, Oregon with the aim of catering for customers taking BCS II and IV rated drug candidates into Phase IIb trials.
Spokeswoman Sheri DuMond told Outsourcing-pharma.com the investment – which broadens Agere’s contract manufacturing offering beyond its previous preclinical to Phase IIa focus – was motivated by client demand as well as wider industry desire for solubilization technologies.
“We are dedicated to building collaborative relationships with clients from the inception of a project…so it is a natural progression for us to continue to expand our cGMP manufacturing capabilities.
“However, even more than that, our goal is to become the recognized leading CRO/CMO in the solubilization space. The industry has undergone a major shift the last 5 years where solubilization technologies are being utilized for record numbers of compounds in the clinic – and enabling recent launches of new drugs.”
The investment follows just weeks after Agere’s neighbour Bend Research – which also provides spray drying services – cited growing pharmaceutical industry demand for bioavailability solutions as the driver for its collaboration with Dow.
Agere’s investment also fits with its existing bioavaiability services, including the hot-melt extrusion (HME) focused manufacturing partnership it formed with Thermo Fisher Scientific in July 2011, which saw the latter firm install HME technology at the CMO’s facility.
The relationship with Thermo Fisher is set to expand according to DuMond.
“We will be making an announcement in a few weeks about our new capabilities for formulation using twin-screw extrusion for granulation and solid dispersions of poorly soluble compounds. This will further enhance Agere’s ability to serve as our clients with a broad set of offerings to overcome oral bioavailability challenges of promising APIs.”