Agere Pharmaceuticals, Inc. has announced that it has added the capability to support clients entering Phase IIb clinical trials with cGMP manufacturing.
The new capacity extends the services to pharmaceutical companies that currently partner with Agere for formulation development to improve oral bioavailability of their BCS II and IV compounds.
By expanding cGMP manufacturing services, Agere now offers its clients one-stop-shopping from concept development through manufacturing for advanced clinical trials.
Outsourcing research and development to CROs is a widespread and growing practice for pharmaceutical and biotechnology companies.
The trend toward relying on a single service provider for research into clinical trial manufacturing eliminates costs, delays and risks inherent in switching vendors.
“We’ve extended our cGMP spray drying capabilities in response to our clients’ requests to continue with Agere as they enter Phase IIb clinical trials,” commented Marshall Crew, Agere’s President and CEO. “This is a natural progression for us, as expanding services delivers efficiencies to our clients.”
Pharmaceutical companies facing solubility challenges with active pharmaceutical ingredients (APIs) depend on Agere’s expertise and scientific approach to enhance the bioavailability of their drugs.
Agere services span formulation design and development into clinical trial drug product manufacturing. All services are offered “à la carte,” allowing companies the flexibility to engage with Agere at any stage in their process.
Agere provides all services on a fee-for-service basis, in which Agere assumes no intellectual property (IP) ownership over work done on behalf of the company’s clients.