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Freeze drying research and development for Diagnostic Polymerase Chain Reaction (PCR) test kits
 

RANGER is a European Commission Framework 7 project, led by Enigma Diagnostics, developing a fully-automated, real-time PCR system which will enable:

• 1) Rapid diagnosis of influenza (both seasonal and pandemic) in the point-of-care environment enabling faster and better informed medical care to reduce suffering and save lives
• 2) Co-ordinated surveillance of influenza incidents and outbreaks, enabling rapid deployment of resources to control disease spread and treat patients.

Biopharma Technology Limited has joined the Ranger project to provide expertise in the field of freeze drying, providing information and advice on both formulation development, container design for the freeze drying process, as well as research and development into an efficient freeze drying cycle enabling the development of a robust and stable material suitable for use in a range of different environments. Biopharma Technology Limited has extensive experience in freeze drying research and development; having assisted a number of companies who needed to freeze dry their diagnostic formulations.

RANGER is a two and a half year programme initiated in July 2007. It will support the development of the fully-automated, real-time PCR system as far as studies in clinical environments in the United Kingdom (Health Protection Agency) and Thailand (Queen Sirikit National Institute of Child Health).

Although vaccination is effective against the spread of influenza, the current global vaccination coverage is less than 5% and viral mutation requires constant review of vaccine efficacy. Consequently the most effective means of controlling the spread of influenza is early diagnosis, followed by containment and antiviral therapy. However, currently available diagnostics technologies are not suitable for widespread use in developed & developing countries. Rapid antigen-based tests are insensitive and are not designed to specifically identify influenza sub-types, whilst existing PCR based techniques or microarrays are slow, expensive and require complex laboratory equipment and expertise. Consequently there is an immediate need for a rapid, robust, sensitive and cost effective point-of-care diagnostic for the identification of influenza strains and subtypes which requires minimal expertise to operate & no specialist laboratory equipment.

For more information please visit the website: www.rangerfp7.com

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