MHRA Grants Almac IMP License for its Radiolabelling Service
July 21, 2009
Almac has announced the extension of its radiolabelling services to include drug product – moving the company into the forefront of GMP radiolabelling.
Almac’s customers can access a full range of radiolabelling services for both large molecules (peptides and proteins) and small molecules.
The market is increasingly moving towards GMP requirements for 14C labelling for both API and drug product. Responding to this market demand, Almac has completed its service extension to now include radiolabelling of drug product and QP release. This new service received MHRA approval with an IMP license in May 2009.
The successful MHRA audit built on Almac’s long held reputation as a service provider meeting the highest standards of Quality Assurance.
QA Manager Alan Chambers commented:
“The IMP license award is a major milestone for our radiolabelling offering and now enables Almac to manufacture radiolabelled drug product for direct use in clinical studies. This achievement places Almac at the forefront of the global GMP radiolabelling industry”.
Responding to the news of the success, Almac Chairman and founder, Sir Allen McClay, said:
“I warmly congratulate the Quality Assurance team that were key to this achievement. Quality and Reliability are the standards that will take and maintain Almac at the forefront of our field”.
Almac also offers a fully integrated set of services, RAPIDDTM (Accelerated Process Integrated Drug Development) including API, formulation, analytical, pre-clinical safety assessment and regulatory documentation to complete lead candidate to entry into Phase I clinical trials in under 12 months.
Almac is a US $750m group with over 2,400 employees supplying over 600 companies worldwide – including all the global leaders in the pharma and biotech sectors.
|Denis Geffroy||Roger Johnstone|
|VP Business Development – Almac Sciences||Deben Editorial Services|
|Tel: +44 (0)28 3833 2200||Tel: +44 (0)161 614 1450|
|Mobile: +44 (0) 7834 498942||Mobile: +44 (0)7841 433141|
|Fax: +44 (0)28 3833 2299||Fax: +44 (0)161 614 1450|
Notes to the Editor:
About Almac Group:
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS and Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs over 2,400 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters started in July 2008 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.