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Description of ASTM-E3443 2024ASTM E3443-24Active Standard: Standard Guide for Minimizing the Impact of Stability Testing on Batch Yield of Low Yield Biopharmaceutical ProductsASTM E3443Scope 1.1 The intent of this guide is to discuss and provide recommendations for reducing the volume requirements for the stability assessment of low yield biopharmaceutical products. 1.2 The recommendations include considerations for both drug substance (DS) and drug product (DP). 1.3 The scope of this guide may be applicable to any modality that has yield constraints or small batch size, however the example provided is specific for rAAV gene therapies. 1.4 The need for specific recommendations for low yield biopharmaceutical products has been identified by observing that stability guidance (for example, ICH Q1 and ICH Q5) are mainly designed for large-scale biologic/small molecule products and are not fully applicable to the unique specificities of low yield products (for example, gene therapy). The recommendations focus on strategies for routine stability studies. Development and supporting studies such as freeze/thaw stability are excluded from the scope of this guide. 1.5 Before application to specific products, companies should ensure internal alignment with the proposed approach, including a documented scientific rationale, and discuss as appropriate with applicable regulatory agencies. 1.6 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords biopharmaceutical; optimization; sample volume; stability; yield; ICS Code ICS Number Code 11.100.20 (Biological evaluation of medical devices) DOI: 10.1520/E3443-24 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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