我们何时才能拥有克隆人?从行业角度看典型的 CLD 时间表。

IF 2.5 3区 生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Howard Clarke, Anke Mayer-Bartschmid, Chenxing Zheng, Elizabeth Masterjohn, Falguni Patel, Mark Moffat, Qingxiang Wei, Ren Liu, Robyn Emmins, Simon Fischer, Stephanie Rieder, Thomas Kelly
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引用次数: 0

摘要

细胞系开发(CLD)是生物药物开发过程中一个复杂而又非常关键的过程。为了了解这一关键的工作流程,由 BioPhorum 成员(作者)组成的团队针对典型的 CLD 活动中涉及的活动和工作制定并实施了调查。参加 BioPhorum CLD 工作组的平均 27 位来自不同公司的成员回答了调查,调查涵盖了标准 CLD 流程的三个不同阶段:(1) 转染前,包括载体设计和构建;(2) 转染,包括将载体初次导入细胞以及随后对细胞池的选择和分析;(3) 单细胞克隆和先导克隆选择,包括分离单细胞和确认克隆来源的方法、随后的扩增和筛选流程,以及识别和保存先导克隆的方法。调查范围非常广泛,共包括 341 个问题,分别涉及抗体和复杂分子 CLD 过程。在本调查回顾中,作者解释并强调了抗体开发方面的回答,并在相关情况下对比了复杂分子开发方面的挑战,从而提供了一个全面的行业视角,说明开发 CHO 生产细胞系所需的典型时间和精力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

When will we have a clone? An industry perspective on the typical CLD timeline

When will we have a clone? An industry perspective on the typical CLD timeline

Cell line development (CLD) represents a complex but highly critical process during the development of a biological drug. To shed light on this crucial workflow, a team of BioPhorum members (authors) has developed and executed surveys focused on the activities and effort involved in a typical CLD campaign. An average of 27 members from different companies that participate in the BioPhorum CLD working group answered surveys covering three distinguishable stages of a standard CLD process: (1) Pre-transfection, including vector design and construction; (2) Transfection, spanning the initial introduction of vector into cells and subsequent selection and analysis of the pools; and (3) Single Cell Cloning and Lead Clone Selection, comprising methods of isolating single cells and confirming clonal origin, subsequent expansion and screening processes, and methods for identifying and banking lead clones. The surveys were very extensive, including a total of 341 questions split between antibody and complex molecule CLD processes. In this survey review, the authors interpret and highlight responses for antibody development and, where relevant, contrast complex molecule development challenges to provide a comprehensive industry perspective on the typical time and effort required to develop a CHO production cell line.

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来源期刊
Biotechnology Progress
Biotechnology Progress 工程技术-生物工程与应用微生物
CiteScore
6.50
自引率
3.40%
发文量
83
审稿时长
4 months
期刊介绍: Biotechnology Progress , an official, bimonthly publication of the American Institute of Chemical Engineers and its technological community, the Society for Biological Engineering, features peer-reviewed research articles, reviews, and descriptions of emerging techniques for the development and design of new processes, products, and devices for the biotechnology, biopharmaceutical and bioprocess industries. Widespread interest includes application of biological and engineering principles in fields such as applied cellular physiology and metabolic engineering, biocatalysis and bioreactor design, bioseparations and downstream processing, cell culture and tissue engineering, biosensors and process control, bioinformatics and systems biology, biomaterials and artificial organs, stem cell biology and genetics, and plant biology and food science. Manuscripts concerning the design of related processes, products, or devices are also encouraged. Four types of manuscripts are printed in the Journal: Research Papers, Topical or Review Papers, Letters to the Editor, and R & D Notes.
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