Cobalt
Cobalt Light Systems has received a European Union grant to investigate high-speed quantitative analysis in pharmaceutical manufacturing. The Horizon 2020 grant will allow Cobalt to develop the high-speed analysis market using its transmission Raman spectroscopy (TRS) technology for tablet and capsule manufacturing. TRS is already available in a desktop instrument, but its combination of speed, accuracy and sensitivity to low concentrations of active ingredients make it an ideal fit for demanding production environments.
Cobalt’s desktop TRS100 product is used in quality control laboratories worldwide as an alternative to wet-chemistry techniques for both end-product testing and in-process checking. A single instrument can analyse hundreds of tablets per hour by loading
them into sample trays, but as manufacturing in the pharmaceutical industry becomes leaner and faster the need to test during production is increasing. Off-line testing often requires as few as 10 tablets per batch to be tested; however, new regulations for on-line testing seek to increase sample sizes to 100-10,000 per batch.
A TRS instrument, incorporating Cobalt’s patented Beam Enhancer technology, can measure the active pharmaceutical ingredient (API) concentrations of a whole tablet in as little as 0.01 seconds, which enables a step change in automated tablet testing throughput – alternative technologies take at least 30-120 seconds per tablet. For many pharmaceutical processes, a fast, accurate, automated instrument is a key enabler for removing the need for any post-production testing. Current NIR technologies struggle with low-dose products, thick tablets, tablets with significant moisture content and, in particular, capsules – all of which are strengths of TRS technology.
Darren Andrews, Cobalt’s Business Development Director, said: “High-speed testing means that products can be released immediately after they are produced, which may save €1,000-1,500/£729-1,078 per batch. This is an important piece of the puzzle for practical real-time release testing and continuous manufacturing."
Real-time release testing (RTRT) in both batch and continuous manufacturing processes is an initiative that requires automated analysis during production. In continuous manufacturing, the entire process is seamlessly integrated, from raw material to finished product – like a car production line. Cobalt’s TRS technology is applicable to both batch and continuous manufacturing and can be easily integrated with physical testing instruments to measure weight, potency, hardness and size in seconds.
The Phase 1 Horizon 2020 grant award of €50,000 will fund business development to select a consortium of partners and collaborators and to apply for phase 2 funding of €0.5-2.5M/£0.4-1.8M.