Cobra sites get MHRA clearance

- Last updated on GMT

Related tags: Clinical trials, European union

Cobra Biomanufacturing has received approval from the UK regulatory
authorities for its new clinical trial manufacturing facilities in
Oxford as well as its established unit in Keele.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted the approval after inspecting the new facilities, and gave Cobra the go-ahead to manufacture a diverse range of biopharmaceutical drug substances intended for use at European Union clinical trial sites.

The MHRA license also authorises Cobra to generate specifically coded labelling systems for blinded clinical trials.

With the new licensing, Cobra is fully compliant with the European Union Clinical Trials Directive 2001/20/EC that came into force in the UK on 1 May, said David Thatcher, the firm's chief executive.

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 claims to be 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.

Cobra can carry out aseptic manufacture of a breadth of products that includes viruses, vaccines, recombinant proteins and live cells.

The new approval is good news for Cobra, which has seen profits decline of late as demand for its contract DNA manufacturing services has fallen off.

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