The objective of the overall innovation project is to develop a novel instrument to measure and control pharmaceutical drug potency during manufacture at sub-second analysis speeds. This will significantly reduce the cost of quality testing, reduce the dosage variability that a patient receives, reduce production waste and solvent disposal and address challenging new regulatory testing guidelines. Pharmaceutical companies, in response to regulators (such as the US FDA) setting direction and guidance, need to better understand and control their processes. Real-time release testing (RTRT) and Quality by Design (QbD) are promoted by regulators as their vision of where quality must go; pharmacopeia guidance supports that vision. Cobalt has developed a successful, patented, high speed quantitative analysis technology called transmission Raman spectroscopy (TRS), which measures drug potency of intact tablets and capsules. When used during production (“on-line”) in combination with an automated physical tablet testing system, TRS will enable immediate release of drug product without “off-line” analysis in a quality control (QC) laboratory.

A major part of the diagnosis of any disease but particularly various forms of cancer, is obtained though a biopsy. This involves removing a small sample of tissue, or a few cells, from the patient. These samples, either tissue or cells are then examined by a pathologist looking down an optical microscope. In most cases the sample is stained with a combination of dyes to help gain some contrast. In most cases, based upon visual inspection of the sample a diagnosis is made. This process if far from ideal since it relies on the expertise of the clinician concerned as is subject to intra in inter observer error. Recently a number of proof of concept studies have shown that molecular spectroscopic techniques such as infrared and Raman are capable of distinguishing diseased from non diseased cells and tissue based upon the inherent chemistry contained within the cells. The UK is at the forefront of these developments but there are many hurdles that need to be overcome if this technology is to move from the proof of concept stage through the translational stage and into the clinical setting. It is the belief of the academic community that we are much more likely to overcome these hurdles if we pool our resources, bring in both industrial and clinical partners and work on these generic problems together. This application is for funding to support such a network of partners for the next three years.