| PEER-REVIEWED RESEARCH |
Chunfen Zhang, Dijana Hadziselimovic, Amy Thanavaro, Adeyinka Aina, Chris Edlin, Paul Lopolito
This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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| MANUFACTURING: FILL/FINISH |
Iain MacGilp, Martin Reid
Single-use technologies, modular systems, and robots are on the rise.
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| CLINICAL TRIALS MANUFACTURING |
Agnes Shanley
Increasingly complex trial protocols have added to IMP manufacturing challenges.
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| FACILITY DESIGN |
Mark Witcher, Harry Silver
A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.
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| VIEWPOINT: REGULATIONS |
Elisabeth Corbett, Andrew Teasdale, Shoreh Shabrang, Lina Wong, Nancy Lewen
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
The European Commission's proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
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| ASK THE EXPERT |
Siegfried Schmitt
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
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