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Continuous manufacturing of active pharmaceutical ingredients during drug development. When is the right time to start continuous process development and engineering?

corresponding

JOCHEN BECKER
Evonik Nutrition & Care GmbH, Hanau, Germany
Member of the Scientific Advisory Board – Chimica Oggi / Chemistry Today

The continuous processing of active pharmaceutical ingredients (API) has gained considerable interest in the pharmaceutical industry over the last 20 years. This is reflected by guidelines and articles by the FDA, and its implementation of the emerging technology team (ETT). Such support from regulatory agencies is helping to encourage the utilization of continuous processes to improve the quality of pharmaceutical products by applying advanced technologies in pharmaceutical manufacturing.  Traditionally, the batch reactor was the main and most commonly used reactor type in API manufacture over decades, given its flexibility for multipurpose use. Pharmaceutical process development during chemical, manufacturing, and control (CMC) phases mainly used to focus on synthesis routes and reaction parameters in the process design space set by the stirred tank reactor.

 

Compared to batch processing, continuous processing allows improved control of process parameters and access to a larger process design space; providing options for improved quality, higher safety, and better efficiency. Running reactions and work up proces ...



 

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