Friday December 05 2008 | Biotechnology feed | All feeds
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Friday December 05 2008 | Biotechnology feed | All feeds
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Keele, UK, 21 July 2005 – Cobra Biomanufacturing Plc (AIM: CBF) announced that it has been formally notified by the UK Medicines and Healthcare products Regulatory Agency (MHRA) that its license to manufacture [Manufacturer's Authorisation - Investigational Medicinal Products, (MA(IMP)] at its Oxford Facility has been extended to include manufacture of sterile dosage forms. This authorisation is the result of a recent comprehensive inspection and evaluation of all of Cobra’s manufacturing and quality systems by the Inspection and Enforcement Division of the agency. It extends the legal authority for Cobra to manufacture a diverse range of biopharmaceutical drug dosage forms as well as bulk products such as vaccines, gene therapy products, allergens, immune sera and plant extracted biopharmaceuticals.
Manufacturers Authorisation is a legal requirement in
Europe for any manufacturing relating to clinical materials irrespective of
the final destination of these products.
David Thatcher, Chief Executive of Cobra
Biomanufacturing commented:
“We are delighted to receive an extension to our license at
our Oxford facility. The granting of the MA(IMP) and its extension to cover
manufacture of sterile dosage forms acknowledges two years of investment in
building and quality infrastructure at the Oxford site. Europe leads the way
in the control of quality standards in the manufacture of products for
clinical use and this confirmation of Cobra’s quality systems will be
recognised as a benchmark worldwide.
The high quality of Cobra’s services have already been
recognised/endorsed by over 50 customers on five continents and Cobra has
manufactured over 20 clinical products for clinical evaluation.”
-Ends-
Notes To Editors:
The Clinical Trials Directive (2001/20/EC) regulations provide a statutory basis for:
· Standardisation of procedures for ethical and competent authority consideration and authorisation · GCP standards for commencing and conducting clinical trials · Good Manufacturing Practice (GMP) standards for medicines used in clinical trials · Inspections against internationally accepted principles and standards of GCP and GMP, supported by enforcement powers
Further information:
· One change that the Directive brings is that materials must be released for clinical trials by a qualified person (QP) in the manufacturing company · The QP also has the authority to release imported materials for clinical trials that have been manufactured by GMP outside the EU · Detailed information on Clinical Trials Directive (2001/20/EC) can be found at www.medicines.mhra.gov.uk
About Cobra Biomanufacturing Plc
Cobra Biomanufacturing Plc
is a leading international manufacturer of biopharmaceuticals to the
lifescience industry. Founded in 1992, Cobra provides innovative manufacturing
solutions to the biopharmaceutical industry covering DNA, virus, cellular
therapeutics and recombinant protein products. Cobra was the first company to
develop GMP (Good Manufacturing Practice) standard DNA manufacture in Europe,
with specific expertise in DNA medicines.
Cobra floated on the Alternative Investment Market of the London Stock Exchange in June 2002 raising £7 million and raised a further £5.2 million in May 2003 in order to further expand capacity in Oxford UK
For further information:
Cobra Biomanufacturing Plc Tel: 44 (0) 1782 714 181
David Thatcher, Chief Executive Northbank Communications Eileen Paul Tel: 44 (0) 1260 296 500 Buchanan Communications Tel: 44 (0) 207 466 5000 Tim Anderson/Mark Court/Rebecca Dietrich |
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