|API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.
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| TABLETING |
Anna Novikova
At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.
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| ANALYTICS |
Derek Duncan
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
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| QUALITY |
Wendy Saffell-Clemmer, Elizabeth Joseph
The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
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| OPERATIONS |
Clay Seese
Digital tools, such as building information modeling (BIM) software, improves efficiency for optimizing pharmaceutical facility design.
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| PEER-REVIEWED RESEARCH |
Andreia Lopes, Raquel Barros, Sérgio Silva
Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations
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| FROM THE EDITOR |
Rita C. Peters
The editors welcome technical article contributions from the bio/pharma industry.
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| US REGULATORY WATCH |
Jill Wechsler
Industry and regulators seek global system that reduces regional differences.
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| ASK THE EXPERT |
Siegfried Schmitt
Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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