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新兴的抗体类产品。

Emerging antibody-based products.

机构信息

Mapp Biopharmaceutical Inc, 6160 Lusk Blvd, Suite C105, San Diego, CA, 92121, USA,

出版信息

Curr Top Microbiol Immunol. 2014;375:107-26. doi: 10.1007/82_2012_240.

DOI:10.1007/82_2012_240
PMID:22772797
Abstract

Antibody-based products are not widely available to address many global health challenges due to high costs, limited manufacturing capacity, and long manufacturing lead times. There are now tremendous opportunities to address these industrialization challenges as a result of revolutionary advances in plant virus-based transient expression. This review focuses on some antibody-based products that are in preclinical and clinical development, and have scaled up manufacturing and purification (mg of purified mAb/kg of biomass). Plant virus-based antibody products provide lower upfront cost, shorter time to clinical and market supply, and lower cost of goods (COGs). Further, some plant virus-based mAbs may provide improvements in pharmacokinetics, safety and efficacy.

摘要

由于成本高、生产能力有限以及生产前期时间长,基于抗体的产品无法广泛用于应对许多全球健康挑战。由于植物病毒瞬时表达的革命性进步,现在有了应对这些产业化挑战的巨大机会。本综述重点介绍了一些处于临床前和临床开发阶段、已实现规模化生产和纯化(每公斤生物质毫克级纯化单抗)的基于抗体的产品。基于植物病毒的抗体产品具有较低的前期成本、更短的临床和市场供应时间以及更低的生产成本。此外,一些基于植物病毒的单抗可能在药代动力学、安全性和疗效方面有所改善。

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