Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines
Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines
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DOI：
10.1016/j.biologicals.2016.01.001
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发表时间：
2016-03-01
期刊：
影响因子：
1.7
通讯作者：
Anderson, Karin
中科院分区：
文献类型：
--
作者：
Frye, Christopher;Deshpande, Rohini;Anderson, Karin
最近，一些卫生监管机构要求申办公司提供关于重组DNA（rDNA）衍生生物药品生产细胞系生产实践的大量详细信息。从这些监管机构问题中可能得出的两个推论是：（1）确保生产细胞系的“克隆性”对于评估产品的安全性和有效性至关重要;（2）在没有充分证据证明“克隆性”的情况下，通常需要对细胞系和产品进行额外研究，以进一步确保产品的纯度和均一性。在这里，我们解决的主题“克隆性”在更广泛的背景下，产品质量保证的当前技术和实践，以及讨论一些相关的科学和历史的观点。我们同意生产细胞系的克隆衍生是具有潜在影响的因素之一，但它只是许多因素之一。此外，我们认为，监管重点应主要放在确保实际给予患者的材料的产品质量，以及确保工艺一致性和在产品的整个生命周期内实施适当的控制策略。(C)2016国际生物标准化联盟。由爱思唯尔有限公司出版。保留所有权利。
Recently, several health authorities have requested substantial detail from sponsor firms regarding the practices employed to generate the production cell line for recombinant DNA-(rDNA) derived biopharmaceuticals. Two possible inferences from these regulatory agency questions are that (1) assurance of "clonality" of the production cell line is of major importance to assessing the safety and efficacy of the product and (2), without adequate proof of "clonality", additional studies of the cell line and product are often required to further ensure the product's purity and homogeneity. Here we address the topic of "clonality" in the broader context of product quality assurance by current technologies and practices, as well as discuss some of the relevant science and historical perspective. We agree that the clonal derivation of a production cell line is one factor with potential impact, but it is only one of many factors. Further, we believe that regulatory emphasis should be primarily placed on ensuring product quality of the material actually administered to patients, and on ensuring process consistency and implementing appropriate control strategies through the life cycle of the products. (C) 2016 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.