FDA Bispecific Antibody Development Programs Guidance for Industry
标准简介
Bispecific Antibody Development Programs Guidance for Industry[附网盘链接]是于不久前发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Bispecific Antibody Development Programs Guidance for Industry[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
Bispecific Antibody Development Programs 1
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 office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides recommendations to assist industry and other stakeholders involved in the development of bispecific antibodies. In addition to general considerations, the guidance provides recommendations for specific regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs. Although this guidance is intended for bispecific antibodies, the principles discussed in this guidance may also inform the 2
development of other types of bispecific protein products and multispecific products. This guidance does not discuss development considerations for other multitarget therapies that are 3 antibody cocktails, polyclonal antibody products, or combinations of monoclonal antibodies. This guidance focuses on a range of regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Of note, many aspects of a bispecific antibody development program will be similar to monoclonal antibody development programs. This guidance discusses unique aspects for chemistry, manufacturing, and controls (CMC), as well as nonclinical and clinical development programs for bispecific antibodies. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody development program. 1
This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2
Examples of such products include single domain, antibody mimetics, non-antibody domain, alternative format, T-
cell receptor mimetics, non-immunoglobulin (Ig) domain and non-Ig scaffold. Bispecific protein products target two antigens and, as used in this guidance, the term multispecific product refers to a therapeutic product that targets three or more antigens. 3
In an antibody cocktail, different antibodies are mixed together during manufacturing. In a polyclonal antibody, a mixture of antibodies recognizing either specific or diverse targets is obtained by purification of pooled plasma or serum. In a combination of monoclonal antibodies, separate antibodies are used together. Each of the products can follow its own dosing regimen or can be combined at the time of administration.
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