DTI awards biomolecule contract to CCL

A DTI contract to develop reference standards for biological molecules has been awarded to Cambridge Consultants (CCL). The goal of the project is to sup-port the UK biotech sector by developing standards that promote its competitiveness both in Europe and the US and enable it to meet national and international regulatory standards.

The development of standards is particularly relevant to SMEs, which frequently lack the resources to develop appropriate methods of validation in-house. This will bring the production of biomolecules in line with pharmaceutical compound methodologies.

The project, due for completion in July 2003, is being undertaken in three phases. Commencing with an industry study, the project will deter-mine relevant biomolecules to be included in the standardisation procedure, methods of production, relevant analytical methodologies and regulatory requirements applicable to commercial scale production.

This will allow CCL to develop ways to characterise selected methodologies and prepare validated QA procedures. Current analytical measurement of biomolecules, particularly those that use aerolisation to create stable, dry particulates, can alter the properties of the molecules, producing misleading results. The final stage of the project ensures that the findings and recommendations are disseminated to the UK's manufacturers and potential end users.