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首页> 外文期刊>Biotechnology Progress >Very Large Scale Monoclonal Antibody Purification:The Case for Conventional Unit Operations
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Very Large Scale Monoclonal Antibody Purification:The Case for Conventional Unit Operations

机译：超大规模单克隆抗体纯化：常规单元操作的案例

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Technology development initiatives targeted for monoclonal antibody purification may be motivated by manufacturing limitations and are often aimed at solving current and future process bottlenecks.A subject under debate in many biotechnology companies is whether conventional unit operations such as chromatography will eventually become limiting for the production of recombinant protein therapeutics.An evaluation of the potential limitations of process chromatography and filtration using today's commercially available resins and membranes was conducted for a conceptual process scaled to produce 10 tons of monoclonal antibody per year from a single manufacturing plant,a scale representing one of the world's largest single-plant capacities for cGMP protein production.The process employs a simple,efficient purification train using only two chromatographic and two ultrafiltration steps,modeled after a platform antibody purification train that has generated 10 kg batches in clinical production.Based on analyses of cost of goods and the production capacity of this very large scale purification process,it is unlikely that non-conventional downstream unit operations would be needed to replace conventional chromatographic and filtration separation steps,at least for recombinant antibodies.
机译：针对单克隆抗体纯化的技术开发计划可能会受到制造限制的推动，并且通常旨在解决当前和未来的工艺瓶颈。许多生物技术公司所争论的一个话题是，常规单元操作（如色谱法）最终是否会限制生产单抗。重组蛋白疗法。对使用当今市售树脂和膜的工艺色谱和过滤的潜在局限性进行了评估，评估了一个概念性过程的规模，该过程每年可从单个制造工厂生产10吨单克隆抗体，该规模代表了其中一个。世界上最大的单工厂生产cGMP蛋白的能力。该方法采用简单，高效的纯化流程，仅需两个色谱和两个超滤步骤，其仿照平台抗体纯化流程已在临床生产中产生了10 kg批次基于商品成本和这种大规模纯化过程的生产能力的分析，至少对于重组抗体而言，不太可能需要非常规的下游单元操作来代替常规的色谱和过滤分离步骤。

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