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| Contamination control is evolving from a compliance checklist to a comprehensive, risk-based strategy for sterile drug manufacturing. Emerging USP draft chapters <1110> and <1114> align with EU GMP Annex 1 by emphasizing holistic contamination control, continuous verification, and scientific risk management. Although not yet official, these guidelines signal future regulatory expectations. Manufacturers that proactively strengthen contamination control strategies now will be better positioned to meet global requirements, protect product quality, and safeguard patient safety. Learn more |
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By Hsiang Yun (Zoe) Chi, Independent CMC Professional | Ocular drug delivery faces strong barriers. Choosing between topical and intravitreal routes of administration shape efficacy, safety, and CMC design decisions. | |
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A History Of Inhalation Delivery In 8 Minutes | By Drug Delivery Leader Live | In this Drug Delivery Leader Live online event segment, panelist Nani Kadrichu describes the development and current state of oral and nasal approaches to targeting respiratory and systemic conditions. |
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| Mastering Drug Delivery Device Commercialization | Article | By Sheleagh Dougan and Meredith Canty, SMC Ltd. | Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. |
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| Sterile Delivery Excellence: Meeting Annex 1 Requirements | White Paper | Giovanni Cosmi, Mirko Gabriele, and Andrea Salmaso, Stevanato Group | Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment. |
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