In this interview, NewsMed talks to Dr. James Mencel's Guidance about Scaling Up API Processes. Could you introduce yourself and your experience in the pharmaceutical industry? I obtained a B.S. in ...
Neuland Laboratories will invest $20 million to open a dedicated process-development laboratory and integrated kilo lab at ...
The completed 300g scale-up batch forms part of Dalton Pharma Services' Process Optimization and Intermediate Scale-Up Program and follows the successful completion of process development activities ...
The Food & Drug Administration's recent approval of process analytical technology (PAT) for use in the pharmaceutical industry is being hailed by drug manufacturers because it encourages process ...
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
Process analytical technology (PAT) has reshaped how biomanufacturers monitor and control production, moving quality assurance from end-of-batch laboratory testing into continuous, real-time ...
Process Development Scientists (process chemists) research and develop ways to manufacture products and monitor existing processes and products for quality and efficiency. A process development ...
Process analytical technology (PAT) describes the FDA-endorsed framework for measuring and controlling pharmaceutical manufacturing processes through real-time data collection and analysis. The FDA's ...
Intimate Connectivity Must Be Maintained Throughout the Product’s Lifecycle The link between product specifications and analytical methods throughout a product’s lifecycle makes intuitive sense. One ...
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