扩大用于临床前研究的治疗性抗体的生产规模并进行生产。
Scaling-up and production of therapeutic antibodies for preclinical studies.
作者信息
Feng Yang, Dimitrov Dimiter S
机构信息
NCI-Frederick, National Institutes of Health, Frederick, MD, USA.
出版信息
Methods Mol Biol. 2009;525:499-508, xiii. doi: 10.1007/978-1-59745-554-1_26.
Abstract
Monoclonal antibodies are increasingly used for treatment of various diseases, mostly cancer therapy and auto-immune diseases. New chimeric, humanized, or fully-human antibodies specific to novel or already validated targets are being developed in many academic labs as well as in commercial entities. A validation of antibodies in preclinical settings is an important component of the road from discovery to clinic. Preparing sufficient amount of high-quality antibodies for preclinical studies is a challenge in some cases. This article summarizes protocols used in research laboratories, and is based on our own experience in the establishment of stable clones of CHO cells to scaling-up of tissue cultures for production of antibodies in bioreactors.
摘要
单克隆抗体越来越多地用于治疗各种疾病，主要是癌症治疗和自身免疫性疾病。许多学术实验室以及商业机构都在研发针对新的或已得到验证的靶点的新型嵌合抗体、人源化抗体或全人源抗体。在临床前环境中对抗体进行验证是从发现到临床这一过程的重要组成部分。在某些情况下，为临床前研究制备足够数量的高质量抗体是一项挑战。本文总结了研究实验室中使用的方案，这些方案基于我们自己建立CHO细胞稳定克隆以及扩大组织培养规模以在生物反应器中生产抗体的经验。
相似文献
1
Scaling-up and production of therapeutic antibodies for preclinical studies.扩大用于临床前研究的治疗性抗体的生产规模并进行生产。
Methods Mol Biol. 2009;525:499-508, xiii. doi: 10.1007/978-1-59745-554-1_26.
2
Enabling speed to clinic for monoclonal antibody programs using a pool of clones for IND-enabling toxicity studies.利用 IND 毒性研究用克隆池，使单克隆抗体项目快速进入临床。
MAbs. 2020 Jan-Dec;12(1):1763727. doi: 10.1080/19420862.2020.1763727.
3
Utilizing targeted integration CHO pools to potentially accelerate the GMP manufacturing of monoclonal and bispecific antibodies.利用靶向整合 CHO 池，可能加速单克隆和双特异性抗体的 GMP 生产。
Biotechnol Prog. 2024 Jan-Feb;40(1):e3399. doi: 10.1002/btpr.3399. Epub 2023 Oct 24.
4
A strategy to accelerate protein production from a pool of clones in Chinese hamster ovary cells for toxicology studies.一种用于毒理学研究的加速中国仓鼠卵巢细胞中克隆库蛋白质生产的策略。
Biotechnol Prog. 2017 Nov;33(6):1449-1455. doi: 10.1002/btpr.2467. Epub 2017 Apr 26.
5
Enhanced cell culture performance using inducible anti-apoptotic genes E1B-19K and Aven in the production of a monoclonal antibody with Chinese hamster ovary cells.在利用中国仓鼠卵巢细胞生产单克隆抗体过程中，使用可诱导的抗凋亡基因E1B-19K和Aven增强细胞培养性能。
Biotechnol Bioeng. 2007 Jul 1;97(4):877-92. doi: 10.1002/bit.21222.
6
Generation of reference cell lines, media, and a process platform for CHO cell biomanufacturing.用于 CHO 细胞生物制造的参考细胞系、培养基和工艺平台的生成。
Biotechnol Bioeng. 2023 Mar;120(3):715-725. doi: 10.1002/bit.28290. Epub 2022 Dec 1.
7
A Different Perspective: How Much Innovation Is Really Needed for Monoclonal Antibody Production Using Mammalian Cell Technology?一种不同的视角：使用哺乳动物细胞技术生产单克隆抗体究竟需要多少创新？
Adv Biochem Eng Biotechnol. 2018;165:443-462. doi: 10.1007/10_2018_59.
8
Comparison of commercial serum-free media for CHO-K1 cell growth and monoclonal antibody production.比较 CHO-K1 细胞生长和单克隆抗体生产的商业无血清培养基。
Int J Pharm. 2012 Nov 1;437(1-2):303-5. doi: 10.1016/j.ijpharm.2012.08.002. Epub 2012 Aug 9.
9
Optimization of cell line development in the GS-CHO expression system using a high-throughput, single cell-based clone selection system.使用高通量单细胞克隆选择系统优化GS-CHO表达系统中的细胞系开发。
J Biosci Bioeng. 2015 Sep;120(3):323-9. doi: 10.1016/j.jbiosc.2015.01.002. Epub 2015 Mar 17.
10
Production of humanized antibody against human high-affinity IgE receptor in a serum-free culture of CHO cells, and purification of the Fab fragments.在CHO细胞无血清培养中生产抗人高亲和力IgE受体的人源化抗体及Fab片段的纯化。
Biosci Biotechnol Biochem. 2001 May;65(5):1082-9. doi: 10.1271/bbb.65.1082.
引用本文的文献
1
Therapeutic Antibodies: An Overview.治疗性抗体：概述。
Methods Mol Biol. 2022;2313:1-25. doi: 10.1007/978-1-0716-1450-1_1.
2
An antibody against the F glycoprotein inhibits Nipah and Hendra virus infections.针对 F 糖蛋白的抗体可抑制尼帕病毒和亨德拉病毒感染。
Nat Struct Mol Biol. 2019 Oct;26(10):980-987. doi: 10.1038/s41594-019-0308-9. Epub 2019 Sep 30.
3
Near infrared photoimmunotherapy with an anti-mesothelin antibody.使用抗间皮素抗体的近红外光免疫疗法。
Oncotarget. 2016 Apr 26;7(17):23361-9. doi: 10.18632/oncotarget.8025.
4
Targeting of bone-derived insulin-like growth factor-II by a human neutralizing antibody suppresses the growth of prostate cancer cells in a human bone environment.通过一种人源中和抗体靶向骨源性胰岛素样生长因子-II 可抑制人骨环境中前列腺癌细胞的生长。
Clin Cancer Res. 2010 Jan 1;16(1):121-9. doi: 10.1158/1078-0432.CCR-09-0982. Epub 2009 Dec 22.
本文引用的文献
1
A comparative study of different vector designs for the mammalian expression of recombinant IgG antibodies.用于重组IgG抗体哺乳动物表达的不同载体设计的比较研究。
J Immunol Methods. 2007 Jan 10;318(1-2):113-24. doi: 10.1016/j.jim.2006.10.010. Epub 2006 Nov 13.
2
Efficient expression of recombinant human monoclonal antibodies in Drosophila S2 cells.重组人单克隆抗体在果蝇S2细胞中的高效表达。
J Immunol Methods. 2007 Jan 10;318(1-2):37-46. doi: 10.1016/j.jim.2006.08.017. Epub 2006 Sep 25.
3
Influence of plasmid DNA topology on the transfection properties of DOTAP/DOPE lipoplexes.质粒DNA拓扑结构对DOTAP/DOPE脂质体转染特性的影响。
J Control Release. 2006 Oct 27;115(3):335-43. doi: 10.1016/j.jconrel.2006.08.009. Epub 2006 Aug 18.
4
Human recombinant antimannan immunoglobulin G1 antibody confers resistance to hematogenously disseminated candidiasis in mice.人重组抗甘露聚糖免疫球蛋白G1抗体赋予小鼠对血行播散性念珠菌病的抗性。
Infect Immun. 2006 Jan;74(1):362-9. doi: 10.1128/IAI.74.1.362-369.2006.
5
Production of human monoclonal antibody in eggs of chimeric chickens.嵌合鸡卵中人类单克隆抗体的生产。
Nat Biotechnol. 2005 Sep;23(9):1159-69. doi: 10.1038/nbt1132. Epub 2005 Aug 28.
6
Production of recombinant protein therapeutics in cultivated mammalian cells.在培养的哺乳动物细胞中生产重组蛋白治疗药物。
Nat Biotechnol. 2004 Nov;22(11):1393-8. doi: 10.1038/nbt1026.
7
Appropriate mammalian expression systems for biopharmaceuticals.适用于生物制药的哺乳动物表达系统。
Arzneimittelforschung. 1998 Aug;48(8):870-80.
8
Recombinant human antibodies: linkage of an Fab fragment from a combinatorial library to an Fc fragment for expression in mammalian cell culture.重组人抗体：将组合文库中的Fab片段与Fc片段连接以在哺乳动物细胞培养物中表达。
Hum Antibodies Hybridomas. 1993 Apr;4(2):74-9.
9
Efficient neutralization of primary isolates of HIV-1 by a recombinant human monoclonal antibody.重组人单克隆抗体对HIV-1原始分离株的高效中和作用。
Science. 1994 Nov 11;266(5187):1024-7. doi: 10.1126/science.7973652.
Zotero 插件