Cobra authorised to manufacture broad range of biopharmaceuticals for European Clinical trials
Cobra Biomanufacturing Plc announced that it has received a Manufacturer's Authorisation - Investigational Medicinal Products, (MA(IMP)), from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its clinical trials manufacturing facilities in both Keele and Oxford.
This authorisation is the result of a recent inspection and evaluation by the agency of Cobra's manufacturing and quality systems. It gives legal authority for Cobra to manufacture a diverse range of biopharmaceutical bulk drug substances under contract for clients and to test and release experimental drug products for use in EU clinical trial sites. The license also authorises Cobra to generate specifically coded labelling systems for blinded clinical trials.
Cobra is fully compliant with the European Union Clinical Trials Directive 2001/20/EC that came into force in the UK on 1 May 2004. This new Manufacturers authorisation is required for any manufacturing relating to clinical materials. Prior to the Directive clinical trial materials could be produced without Good Manufacturing Practice (GMP) in facilities that had not been approved by a regulatory agency. Cobra is one of the first companies in the UK that has been approved under the new legislation.
The Directive aims to improve patient protection by manufacturing materials under strict conditions that ensure the same or a similar quality as a licensed product. Under the new Directive all materials for Clinical trials in Europe will have to be produced under GMP. Another significant change is that non-EU organisations who wish to carry out clinical trials in the EU, will be forced to produce their clinical trial materials by an authorised manufacturer.
The granting of the (MA(IMP)) acknowledges almost five years of GMP compliance at Cobra and provision of a reliable and responsive biomanufacturing service to over 40 companies. The high quality of Cobra's clinical trial products have already been recognised/endorsed by Danish and Swedish regulatory agencies who adopted the Directive earlier than the UK.
David Thatcher, Chief Executive of Cobra Biomanufacturing commented:
"We were delighted to receive our license for both our original Keele facility and our recently opened Oxford facility. At Cobra we carry out aseptic manufacture on a breadth of products that includes viruses, vaccines, recombinant proteins and live cells. Our new facility has seven GMP suites enabling multiple products to be manufactured in parallel. We specialise in manufacturing challenging biopharmaceuticals with high potency or materials with Orphan drug status. The new Directive means that we will be able to broaden our offering throughout the entire clinical trial process and is an important stepping stone to Cobra's entry into commercial phase manufacture of biopharmaceuticals."
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Topic world biopharmaceutical manufacturing
Biopharmaceutical production plays a crucial role in the development and manufacture of biologics, which are essential for the treatment of various serious diseases. Various key technologies and processes of the modern biopharmaceutical industry are used, such as cell cultures, fermentation processes and the purification of biological substances, which are necessary for the production of vaccines, monoclonal antibodies and other biological drugs.
Topic world biopharmaceutical manufacturing
Biopharmaceutical production plays a crucial role in the development and manufacture of biologics, which are essential for the treatment of various serious diseases. Various key technologies and processes of the modern biopharmaceutical industry are used, such as cell cultures, fermentation processes and the purification of biological substances, which are necessary for the production of vaccines, monoclonal antibodies and other biological drugs.
