July 11, 2011 -- Celebrations are due at Cambridge-based Melbourn Scientific, a leading provider of analytical and formulation support for the pharma and biotech industries: it has gained a manufacturing licence following a successful UK MHRA GMP (Good Manufacturing Practices) audit. The company has expanded its facilities and can now offer manufacture of product for clinical trials.
Carol Barbour, Director of Quality, explains that Melbourn will be able to provide a comprehensive service for clients from first analysis of an interesting molecule to manufacture of product for Phase I and II trials. She says:
“Melbourn has been an approved contract testing laboratory for some time, and this new manufacturing licence adds significant value to our portfolio of services. Now in addition to support for formulation development, analytical method development and validation and stability studies we can provide small scale production and batch release of product for use in clinical trials.
“A ‘one-stop’ approach to early drug development will benefit clients who want to accelerate new product and device advances. Our analytical approach allows us to troubleshoot and address issues early on. This will provide a high degree of confidence in the final formulation. It will also be welcomed by large pharma clients who need routine testing and a fast turnaround,” she said.
Melbourn has doubled the size of its laboratory space in recent years to include special project rooms, a formulation suite, manufacturing facilities and increased stability storage. It has a dedicated team of analysts and formulators, one of the largest teams in Europe. It also benefits from a stable workforce so clients placing projects can usually work with the same team as before, which offers considerable consistency in the approach.
“By offering our clients analysis, formulation development and manufacture on one site, it is possible to screen a wide range of formulations, in a cost and time effective manner, in order to identify those most likely to succeed,” Carol continues.
“Although early research does not need to be performed in accordance with GMP, having development work performed by a GMP accredited laboratory gives confidence in the results. Following established protocols also helps to facilitate any due diligence processes if IP is being shared with external partners and can potentially increase the value placed on this data.”
In addition, Melbourn can also offer Qualified Person (QP) services to certify batches of medicinal products prior to use in a clinical trial or release for sale within the European Community or European Economic Area.
“Once the product is ready to go to the clinic, with our new MIA (IMP) licence, Melbourn can now manufacture the product and have QP available to release the product,” Carol explains.
The MHRA is the regulatory body within the UK, which scrutinises all licensed medicines in the UK to ensure that medicines meet acceptable standards on safety, quality and efficacy, and therefore protect the health of the public. They therefore audit all companies working within this area to assess the compliance of the facilities with GMP and to assure the integrity of the data being submitted.
Having a successful audit confirms that a facility is working in compliance with GMP and gives clients added confidence in the work performed on their behalf.
For media enquiries: Please contact Rachel Holdsworth/Rebecca Nesbit, 01954 202789, rebecca@holdsworth-associates.co.uk,
Melbourn Scientific: Martin Westcott, Business Development Manager, Melbourn Scientific Ltd, 01763 261648, martin.westcott@melbournscientific.com, www.melbournscientific.com
