Melbourn Scientific is to set up the new pharmacopoeial service and have invested in equipment and reagents required to run a range of tests that include Organic Volatile Impurities (OVI's), Kjeldahl nitrogen determination, sulphated ash, optical rotation and refractive index determinations.
Pharmacopoeial testing - the identification of simples and the preparation of compound medicines, is compulsory for all new products. Pharmacopoeial testing requires specialist skills that are taught at few universities because it requires expensive reagents and an investment in specialist glassware and other equipment. It is rarely economical for companies to retain people with these skills for the few occasions when the tests are needed.
The demand for these services has not been met and there are fewer and fewer companies with the specialist skills needed to perform the tests. "We have found that our analysts enjoy the challenge of pharmacopoeial which puts their skills to the test, the methods are very exact and the reagents specific to a particular test," said managing director Steve Westcott.
"The skills required to make it work are not easy to pick up and our analysts have decades of accumulated experience to call upon and it gives them an opportunity to use them."
Companies involved in pharmacopoeial testing provide drug discovery services to pharmaceutical and biotechnology companies. The services are based on proprietary combinatorial chemistry and high-throughput screening technologies. Using proprietary technologies and processes, scientists identify and optimise novel drug candidates through research collaborations.
Westcott commented that it was easy to calculate the benefits of outsourcing pharmacopoeial testing - made evident by client's responses.
"A number of clients had requested pharmacopoeial tests and we had made an investment to support this, the natural progression was to build on this and offer a complete range of tests. Response from clients has been enthusiastic."
Melbourn Scientific, which is located near Cambridge in Eastern England, currently employs about 40 analysts at its laboratories and has grown organically to provide a range of contract analytical services to the pharmaceutical industry.