生物制剂生产过程中体外细胞年龄(LIVCA)下限的建立。

Q3 Medicine
Barbara Tevelev, Sharyn Farnsworth, Sarah Kaminsky-Pontell, Urška Verbovšek, Guanghua Benson Li
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引用次数: 0

摘要

本白皮书探讨了目前生物制剂生产中建立体外细胞年龄限制(LIVCA)的实践和行业经验。根据国际人用药品技术要求协调委员会(ICH),细胞底物的表征和测试是生物技术和生物产品控制的关键组成部分。监管机构要求在生物制品商业生产中使用主细胞库(MCB)和工作细胞库(wcb)建立LIVCA,以证明生产过程中使用的细胞的最大体外细胞年龄在细胞培养扩增和生产过程中对产品质量和工艺一致性没有影响。本白皮书回顾了LIVCA的基因型、表型和产品质量表征方法,同时强调了使行业实践与监管期望保持一致以加快市场批准的必要性。它讨论了实施LIVCA的策略、监管指南、塑造不同行业实践的期望,并概述了批准经验,包括基于在中试工厂规模下扩展的生产单元或使用代表性缩小模型获得的数据。在BioPhorum运营集团(BPOG)协调的行业调查基础上,通过涉及行业领导者的合作方法,我们的目标是简化和加快LIVCA时间表,同时确保稳健的制造流程和遵守高合规标准,因为公司设计和实施他们的LIVCA战略高效和有效地支持商业化应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Establishment of Limit of In Vitro Cell Age (LIVCA) for Biologics Manufacturing Process.

This white paper explores current practices and industry experiences for establishing the Limit of In Vitro Cell Age (LIVCA) in biologics manufacturing. As per the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH), characterization and testing of banked cell substrate is a critical component of the control of biotechnological and biological products. Regulatory agencies require the establishment of LIVCA for the use of master cell bank (MCB) and working cell banks (WCBs) in commercial manufacturing of biologics to demonstrate that the maximum in vitro cell age of cells used in the production process has no impact on product quality and process consistency over the duration of cell culture expansion and manufacturing process. This white paper reviews the methodologies for genotypic, phenotypic, and product quality characterization for LIVCA while highlighting the necessity of aligning industry practices with regulatory expectations to expedite market approval. It discusses the strategies for implementing LIVCA, regulatory guidelines, expectations that shape different industry practices, and provides an overview of approval experiences including those based on data derived from production cells expanded under pilot plant scale or using representative scale-down models. Through a collaborative approach involving industry leaders based on an industry-wide survey coordinated by the BioPhorum Operations Group (BPOG), we aim to streamline and accelerate LIVCA timelines, while ensuring robust manufacturing processes and adherence to high compliance standards as companies design and implement their LIVCA strategies efficiently and effectively to support commercialization applications.

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来源期刊
CiteScore
1.90
自引率
0.00%
发文量
34
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