Consultancy in bio-assays, bio-analytical technologies and protein analytics, including drug specification setting
Analysis of proteins and biochemicals lies at the heart of drug discovery and development. Businesses involved in discovery and process development need to fully engage with a range of analytical functions, both within and without their organisation. For businesses wishing to develop or introduce new analytical methodologies or services, my bio-analytical consultancy can help them to better understand and access the complex analytical needs of the drug and biological discovery functions within bio-businesses. I also help my clients to properly resource and integrate analysis into their drug discovery and development programs.
My first exposure to the importance of well-designed bio-analytical methods was when detecting and isolating the tiny amounts of proteins present in cell homogenates. The development of innovative but robust methods for high-throughput screening at Glaxo was my next growth experience. This was followed by the need to develop and integrate a wide range of assays to manufacture and release a recombinant DNA derived protein for clinical trials at Searle and Monsanto. As a result, I obtained considerable experience in developing and implementing biochemical, separations, cellular and immunological-based assays for measuring analytes in complex biological mixtures. In addition, as analytical director at Monsanto I built and directed Good Laboratory Practice (GLP)-compliant analytical groups to develop and run validated methods for measuring biologicals and chemicals.
Value of Analytical Technology
A UK-based instrument development company wanted to know if there was any potential for their proprietary analytical technology to be used for high throughput screening applications. I told them that its high sample cost and low throughput meant that it would have very little application in that area. However, I felt that it would have considerable value for the diagnostics business and was able to put them in contact with key players in this market.
A bio-pharmaceutical discovery company had outsourced the mammalian cell production of their lead protein. This work was going well, but they were concerned about the regulatory and quality control aspects of a PEGylation step. With my experience in GMP manufacturing and specification setting, I was able to suggest the sort of pre- and post-PEGlyation specifications required. I also advised them on the GMP requirements for the chemical derivatisation and discussed the in-process controls that might be established. This helped to reassure them that such a product could be made to acceptable quality standards.