Discovery and Exploration of a Rapid Bioluminescence Technology in the Health Care Industry
Richard A. Boehler, M.S.
Paperback (8.25x11) 9781434386557
Pharmaceutical Manufacturing Team of the Year Award
Wyeth won big in our 3rd Annual Team of the Year competition, with the Pearl River (N.Y.) Biotech Fill-Finish team taking the Gold award and the Consumer Healthcare External Supply “Project ICE” team earning the Silver award. Luitpold Pharmaceuticals’ Microbiology team bagged the Bronze award, and the FDA/Conformia QbD Workshop team commanded a special Catalyst award.
Rapid ATP Bioluminescence
American Society For Microbiology Presentation (Atlanta, Georgia).
How Early Communication with FDA Sped Up One RMM Implementation
Rapid Microbial Methods (RMMs) offer another tool that can facilitate Lean Manufacturing in biologics and pharmaceutical manufacturing, and taking the industry a few steps closer to parametric product release. Proactive communication with FDA reviewers was instrumental in getting approval for one RMM implementation project at a major pharma company. Rich Boehler discusses how his team at a previous (unnamed) employer went about the implementation.