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 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 implementation of 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 effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.
Presented by Dr. Udayanath Aich Associate Director at Bristol-Myers Squibb
Dr. Udayanath Aich has an extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. He then decided to move to M.I.T to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.