Potent Compound Processing in the Merck Rahway FLEx Center
Senior Scientist, Merck & Co Inc
The FLEx Center (Formulation, Laboratory, and Experimentation Center) is a GMP clinical and developmental drug product pilot opening in Rahway in 2022. It covers multiple modalities: Oral Solid Dosage, Animal Health, and Sterile manufacturing. Almost all the equipment within FLEx is portable – that is, it does not have a dedicated processing space. The equipment will be moved from a clean storage room into the processing area where the batch will be run. Following the batch, the equipment will be cleaned and returned to clean storage. The FLEx center contains both modular (movable glass walls) and podular (movable processing area) manufacturing spaces. The focus of this talk will be on the technology used to safely process highly potent API powders (OEB 4/5) for specific unit operations within Oral Solid Dosage.
Date and Location
Jan 20th, 2022
About the speaker
Rob O'Connor is a Senior Scientist at Merck & Co., Inc., Rahway, NJ, USA. He has been at Merck for the past 6 years, primarily in small molecule drug substance development. Rob started in Chemical Engineering R&D in the Particle Engineering Lab, becoming an SME in amorphous dispersions, crystallizations, dry milling, and novel drying unit operations. In 2019 he became a plant engineer in a GMP drug substance pilot plant, designing and executing wet chemistry batches.
Rob is currently a process engineer in Pharmaceutical Sciences and Clinical Supply, specifically in the Oral Solid Dosage division of the Rahway FLEx Center (Formulation, Laboratory, and Experimentation Center), a brand new GMP drug product pilot plant opening this year. The FLEx center will be capable of making batches up to 70kg for development and clinical supply.
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