MHRA Approves Molecular Profiles' Clinical Manufacturing Facility
Built over the last year, the £9m ($13.5m) clinical manufacturing plant in Nottingham, UK - which adds six GMP suites, laboratories and a clinical packing area in order to support Phase I and Phase II clinical trial projects – opened its doors recently after receiving approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
The new facility will expand upon the contract manufacturing organization’s (CMO) capabilities in analytical services, CEO Nikin Patel told Outsourcing-Pharma.com, allowing the firm to support client projects all the way through to clinical trial supply.
“With 15-6 years of experience in high end pharmaceutical analysis,” he said, “Molecular Profiles has a breadth of offerings not commonly found in CMOs.” As an example, Patel said the firm would be able to support a client itself if there were issues in the development stage.
The 30,000sq ft facility will handle mostly solid dosage form manufacture for human clinical trials and can deal with highly potent compounds up to OEB 4 level with manufacturing batch scales of up to 30kg.
Partnerships
Molecular Profiles Vice President, Steve Kemp, also spoke to Outsourcing-pharma.com regarding the ongoing strategic alliance with Onyx Scientific.
“We have a very good partnership with Onyx, who do early stage synthesis of and manufacture of APIs,” he said. Onyx’ parent body – Indian company IPCA – manufacture large scale volumes of APIs and solid dose and therefore, Molecular profiles fits right between making the formulation for phase I and II trials.
As for future partnerships, Patel said the CMO would be reluctant to duplicate the early phase synthesis and solid state capability provided in the Onyx/IPCA alliance but instead hoped to complement its client services by adding packaging capabilities through another collaboration.
“We are looking to make a deal soon and are currently in talks with several potential packaging partners.”
