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PAT Paves the Way for Continuous ManufacturingProcess analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.
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PAT Paves the Way for Continuous ManufacturingProcess analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.
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Controlled Release from Porous PlatformsThe authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.
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Surface Neutralization SystemA new, robust method for protein elution from ceramic hydroxyapatite.
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Piloting Track-and-Trace ImplementationVirtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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The Link Between Manufacturing and Commercialization in Gene and Cell TherapiesThe highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
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Worldwide Pharmaceutical Meetings—A Place for SharingWorldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.
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Strong CMO Relationships Expand Opportunities for Sponsors-Stability testing for clinical trial materials -New services for oral solid dosage forms -Sourcing global clinical trials in the U.S. and Japan
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Industry Perspectives#wpbut {border: 3px solid #245998; border-radius:40px; border-color: #245998; padding: 15px 30px; font-size:15px !important;} #wpbut:hover {background: #15355a; color: #fff !important; transition: .5s;}
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Carbohydrates For InjectionElham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.
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Establishing Limits for Dermal Absorption of Elemental ImpuritiesCurrent guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
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Data Integrity: Getting Back to BasicsEnsuring data integrity involves effort on an individual and global basis.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 GuidanceSusan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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Utilizing Run Rules for Effective Monitoring in ManufacturingTo enable efficient monitoring systems, life-science companies need to effectively apply run rules.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
