Company: Gilead Sciences
Liaison(s): Gerard Jensen
For purposes of quality control, incoming identification testing of both raw materials and active drug substances typically involves confirmation of molecular identity. The KGI team explored the use of a portable device, based on RAMAN spectroscopy, for rapid identification of incoming raw materials and active drug substances at Gilead Sciences. The advantages of Raman spectroscopy lie in its ability to sample materials inside the packaging outfit, ease of use, and lack of sample preparation. Such testing can be performed by the Quality Assurance group upon receipt of the material, saving members of Quality Control time and associated costs in performing other types of assays. The team carried out a technical evaluation of the system to assess and optimize performance characteristics, to determine testing and environmental constraints, and analyze generated spectra from given compounds. In addition, the team developed a library of relevant compounds to grade and confirm identity at the point of testing without compromising packaging. Also, the KGI team explored and developed a road-map of the compendial and regulatory requirements for implementation with Gilead commercial products. Possible avenues were discussed with FDA and USP contacts, and referenced with FDA guidance documents. Concurrently, the team developed a scheme to validate the Raman methodology, to enable use with commercial products. The final report creates a pathway for Gilead to use to “Go-live” with this technology for Gilead’s commercial products.