During development of quality solid dosage forms, fluid bed granulation is often employed due to its adaptable processing capabilities with respect to different Active Pharmaceutical Ingredients (APIs), formulations and in-house experience. Characterization of particle size and distribution are critical to building process understanding and part of an overall control strategy for solid dosage development. In this online seminar, the use of inline FBRM® C35 technology is shown to provide critical insight in to fluid bed operations. This data has been linked/modeled to downstream CQA’s of the product leading to real-time feedback during granulation.
Guest presenter – Steve Mehrman
Our guest speaker Steve Mehrman, from Johnson & Johnson Research & Development in Spring House, PA, earned his BS in Chemistry from Minnesota State University followed by a PhD in Organic Chemistry from the University of Nebraska working with Prof. James Takacs on Organo-Metalic Catalysis. Steve then joined Johnson & Johnson P.R.D. in 1999 working with Ahmed Abdel-Magid in chemical development focused on building new reductive amination methodology and developing scalable chemical processes focusing on crystallization. A large focus of this work was on utilizing automated equipment and integration including: Raman, FBRM® , NIR, MultiMax™ reactors and other custom lab equipment to support scale-up with real time process analytics. For the last two years Steve has been working in drug product development supporting PAT (FBRM® C35, NIR, Raman) for solid dosage development and tech transfer.
Related Topics: fluid bed, dissolution, FBRM® C35, solid dosage forms, Steve Mehrman, Johnson & Johnson, J&J, Active Pharmaceutical Ingredients, APIs, formulations, particle size, particle distribution, process understanding, solid dosage development, chemical development, particle characterization, crystallization, PAT, Process Analytical Technology, process analytics, drug product development, tech transfer