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首页> 外文期刊>Biotechnology Progress >Antibodies and genetically engineered related molecules: Production and purification [Review]
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Antibodies and genetically engineered related molecules: Production and purification [Review]

机译：抗体和基因工程相关分子：生产和纯化[综述]

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摘要

Antibodies and antibody derivatives constitute 20% of biopharmaceutical products currently in development, and despite early failures of murine products, chimeric and humanized monoclonal antibodies are now viable therapeutics. A number of genetically engineered antibody constructions have emerged, including molecular hybrids or chimeras that can deliver a powerful toxin to a target such as a tumor cell. However, the general use in clinical practice of antibody therapeutics is dependent not only on the availability of products with required efficacy but also on the costs of therapy. As a rule, a significant percentage (50-80%) of the total manufacturing cost of a therapeutic antibody is incurred during downstream processing. The critical challenges posed by the production of novel antibody therapeutics include improving process economics and efficiency, to reduce costs, and fulfilling increasingly demanding quality criteria for Food and Drug Administration (FDA) approval. It is anticipated that novel affinity-based separations will emerge from the development of synthetic ligands tailored to specific biotechnological needs. These synthetic affinity ligands include peptides obtained by synthesis and screening of peptide combinatorial libraries and artificial non-peptidic ligands generated by a de novo process design and synthesis. The exceptional stability, improved selectivity, and low cost of these ligands can lead to more efficient, less expensive, and safer procedures for antibody purification at manufacturing scales. This review aims to highlight the current trends in the design and construction of genetically engineered antibodies and related molecules, the recombinant systems used for their production, and the development of novel affinity-based strategies for antibody recovery and purification.
机译：抗体和抗体衍生物构成了目前正在开发的生物制药产品的20％，尽管鼠类产品早期失效，但嵌合和人源化单克隆抗体现已成为可行的治疗方法。已经出现了许多基因工程改造的抗体结构，包括可以向靶标如肿瘤细胞传递强大毒素的分子杂种或嵌合体。然而，抗体治疗剂在临床实践中的普遍使用不仅取决于具有所需功效的产品的可获得性，还取决于治疗的成本。通常，在下游加工过程中会产生治疗性抗体总生产成本的很大一部分（50-80％）。新型抗体治疗剂的生产带来的关键挑战包括提高过程经济性和效率，降低成本以及满足食品药品管理局（FDA）批准的日益严格的质量标准。可以预期，基于针对特定生物技术需求的合成配体的开发将出现基于亲和力的新型分离方法。这些合成的亲和配体包括通过合成和筛选肽组合文库获得的肽，以及通过从头设计和合成而产生的人工非肽配体。这些配体的出色稳定性，更高的选择性和较低的成本可导致更大规模，更便宜，更安全的抗体纯化程序。这篇综述旨在突出基因工程抗体和相关分子的设计和构建，用于其生产的重组系统以及基于抗体和回收的新型基于亲和力的策略的开发方面的当前趋势。

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