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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 Nathan Parker, principal consultant, Parker Biopharmaceutical Consulting | The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic. |
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| Safe Handling Of Monoclonal Antibodies: Best Practices | Article | By Claus Exenberger, Single Use Support | Explore safety measures for handling mAbs in production to meet strict requirements that prevent contamination, product loss, and exposure to cytotoxic agents or radioisotopes. |
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| Webinar: Environmental Monitoring vs. Good Aseptic Technique | Join Particle Measuring Systems on April 23rd to learn what suitable environmental monitoring is required to meet the requirements of ISO and the regulatory bodies. We will look at manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems. Click here to learn more. |
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A conversation with Melinda McCants, Andrew Goldman, and Sonia Schwantes, members of BioPhorum | Three long-standing members of BioPhorum’s Risk and Business Continuity Workstream talk about their approaches to risk management, continuity, and what they learned from the pandemic. |
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| Empowering Biopharma With Single-Use Cryopreservation Solutions | Article | By Ian Burdick, MBA, and Evan Hagen, Charter Medical | Explore four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications. |
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| Connect With Bioprocess Online: |
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