What is it about?
The Manufacturing Classification System Working Group has published our second paper. This follows up on our initial outline of the MCS by looking at real-world applications. Have you ever wondered how companies make their commercial drug product processing decisions and what factors are important? This paper looks at data from over 400 regulatory filings from the last 20 years along with specific company case studies to give insight into possible answers. We also consider future trends in pharmaceutical manufacture such as continuous processing.
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Perspectives
The team is always looking for feedback so it would be great if you could read the paper and let us know your thoughts.
Michael Leane
Bristol-Myers Squibb Co
Read the Original
This page is a summary of: Manufacturing classification system in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing, Pharmaceutical Development and Technology, November 2018, Taylor & Francis,
DOI: 10.1080/10837450.2018.1534863.
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