| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.
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| STERILE FILTRATION |
Cynthia A. Challener
Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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| PEER-REVIEWED |
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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| QUALITY |
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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| FROM THE EDITOR |
Rita C. Peters
FDA and USP take sides in debate on biologic drug standards.
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| OUTSOURCING OUTLOOK |
Susan Haigney
The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.
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| US REGULATORY WATCH |
Jill Wechsler
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
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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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