There has been much recent focus on the regulatory emphasis and the relative importance surrounding clonal derivation of mammalian production cell lines used in the manufacture of recombinant DNA-derived biopharmaceuticals. This interest has led to an ongoing discussion between regulators and industry on how this topic is evaluated and the role it plays in the development of a new biopharmaceutical. Herein the authors describe that the clonal derivation of the production cell line is a factor with potential impact on product quality, and thus should not be considered separately from, but rather in the context of all elements comprising the control strategy necessary to support approval of a regulatory application. Considerations for how clonal derivation of cell banks and clonal variation thereof may be viewed during the lifecycle of a biopharmaceutical product is provided.

近来，人们一直将注意力集中在用于生产重组DNA衍生的生物药物的哺乳动物生产细胞系的克隆衍生的监管重点和相对重要性上。这种兴趣已导致监管机构和业界之间就该主题如何评估及其在开发新生物制药中的作用进行了持续的讨论。本文作者描述了生产细胞系的克隆衍生是对产品质量有潜在影响的因素，因此不应与生产细胞系的克隆因素分开考虑，而应在构成支持批准某项产品所必需的控制策略的所有要素的背景下进行考虑。监管应用。