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A Risk-Based Approach to Data IntegrityHeightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
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A Risk-Based Approach to Data IntegrityHeightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
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A Risk-Based Approach to Data IntegrityHeightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
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Labs on the Frontlines: Balancing Re-Entry and the Race to a COVID-19 CureHow real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.
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Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
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Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
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Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
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Environmental Containment Performance—Is There Accountability?Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
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Environmental Containment Performance—Is There Accountability?Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
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Managing Clinical Development Risk: Pharma and CRO ReportThe relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.
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Are IPRs Impacting the Pharmaceutical Industry?As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.
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Requirements for Product Technology TransferSusan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.
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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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The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial SuccessSmall pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
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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;}
