MAPPING FUTURE TECHNOLOGY NEEDS FOR REAL TIME RELEASE TESTING

Presented by Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb

Real-time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of the product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of the implementation of the roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real-time release (RTR). The URS documents will promote the effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.

#realtimerelease