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| The introduction of ICH Q14 to analytical procedure development provides guidance on the recommended approach to assay development and the justifications regulatory bodies require to demonstrate the development of a method. While applying an AQbD approach may require more upfront work, the advantages are a better understood and more robust method, with greater regulatory flexibility. Learn more about ICH Q14 and how proactive application can save time and cost over the method development life cycle. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | There is pressure to accelerate programs out of research, and into development. Then, despite the complexity of new drugs, therapies and technologies, process development chemists are asked to quick-step to clinical grade, and commercial-ready material. For their part, CDMOs need to react to it all. |
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Navigating Grades And Sources Of Materials In Drug Manufacturing | By Allison Radwick, RPh, Ph.D., U.S. Pharmacopeia | From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality. |
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Optimizing The Formulation For A Monoclonal Antibody | Case Study | MilliporeSigma | An emerging biotech company sought help developing a formulation for a monoclonal antibody. Review the solution that delivered an optimized formulation within an aggressive timeline and budget. |
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Managing Outsourcing For Complex Formulations | Q&A | Ajinomoto Bio-Pharma Services | Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with LNP formulation is the journey into the unknown. |
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Supply Chain Management | Singota Solutions | Discover how key partnerships can help provide clients insight into potential product degradation inflicted during the final product distribution process and provide transport validation support. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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