FDA COVID-19 Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
标准简介
COVID-19 Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity[附网盘链接]是于不久之前发布的FDA标准，适用于美国。标准截图
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标准文档说明
标准文档类型为COVID-19 Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Contains Nonbinding Recommendations COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. Due to the current public health emergency, FDA is issuing this guidance to assist sponsors in 1
the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. A critical quality control measure for these products is the development 2
and implementation of a potency assay(s) adequate to ensure that each lot is consistently 3
produced with the potency necessary to achieve clinical efficacy and that such potency is maintained over the shelf life of the product. Typically, FDA engages with sponsors regarding their development of appropriate potency assays over the course of drug development; these 1
The term protein is one of the statutory categories of biological products (section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1))). Under 21 CFR 600.3(h)(6), a protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. 2
See 21 CFR 610.10. 3
Under 21 CFR 610.3(s), potency is interpreted to mean the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result. 1
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