| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
For many processes involving hazardous chemistry, running in flow mode has several advantages.
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| LYOPHILIZATION |
Agnes Shanley
A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
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| PEER-REVIEWED |
Máté Mihalovits, Sándor Kemény
In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
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| FACILITY DESIGN AND OPERATIONS |
Jennifer Markarian
Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.
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| GOOD DISTRIBUTION PRACTICES |
Ian Elliot
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
The European Commission's effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
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| OUTSOURCING REVIEW |
Susan Haigney
In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
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| ASK THE EXPERT |
Susan J. Schniepp
SOPs need to reflect a company's specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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