| STERILE FILTRATION |
Cynthia A. Challener
Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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| MANUFACTURING |
Feliza Mirasol
Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.
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| PEER-REVIEWED RESEARCH |
Mark Witcher
To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
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| ANALYTICS |
Felicity Thomas
This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.
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| PACKAGING |
Hallie Forcinio
Today's quality inspection systems for pharmaceutical packaging catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.
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| DATA INTEGRITY |
Agnes Shanley
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
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| EDITOR'S COMMENT |
Felicity Thomas
The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
Will EMA's draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
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| ASK THE EXPERT |
Siegfried Schmitt
Cultural and language discrepancies during an audit can be resolved using what many call a "playbook," says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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