CLINICAL SUPPLY MANUFACTURING ARTICLES
Survey Findings: How Are IDMP Readiness Efforts Progressing?
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
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Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.
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Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.