实现抗体疗法全球访问的流程和操作策略

StephenW

Process and Operations Strategies to Enable Global Access to Antibody Therapies
Brian Kelley  1 , Todd Renshaw  1 , Michael Kamarck  1
Affiliations
Affiliation

    1
    Vir Biotechnology, San Francisco, California.

    PMID: 33686779 DOI: 10.1002/btpr.3139

Abstract

Few monoclonal antibodies are currently approved for treating infectious diseases, but multiple products are in development against a broad range of infectious diseases, including Ebola, influenza, hepatitis B, HIV, dengue, and COVID-19. The maturity of mAb technologies now allow us to identify and advance neutralizing mAb products to the clinic at "pandemic pace", as the pipeline of mAbs targeting SARS-CoV-2 has demonstrated. Ensuring global access to these products for passive immunization, however, will require both low manufacturing cost and multi-ton production capacity - particularly for those infectious diseases where the geographic burden falls mostly in low- and middle-income countries or those with pandemic potential. Analysis of process economics and manufacturing technologies for antibody and other parenteral protein therapeutics demonstrates the importance of economies of scale to reducing the cost of goods for drug substance manufacturing. There are major benefits to convergence on a standardized platform process for antibody production that is portable to most existing very large-scale facilities, carries low risk for complications during process transfer and scale-up, and has a predictable timeline and probability of technical and regulatory success. In the case of an infectious disease with pandemic potential which could be treated with an antibody, such as COVID-19 or influenza, these advantages are paramount. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

StephenW

实现抗体疗法全球访问的流程和操作策略
布莱恩·凯利1，托德·伦肖1，迈克尔·卡马克1
隶属关系
联系

    1个
    维尔生物技术公司，加利福尼亚州旧金山。

    PMID：33686779 DOI：10.1002 / btpr.3139

抽象的

目前很少有单克隆抗体被批准用于治疗传染病，但是针对多种传染病的多种产品正在开发中，包括埃博拉病毒，流感，乙型肝炎，HIV，登革热和COVID-19。现在，mAb技术的成熟使我们能够以“大流行的速度”识别和中和mAb产品，并将其推向临床，正如针对SARS-CoV-2的mAb产品流水线所证明的那样。但是，要确保全球获得这些产品进行被动免疫，将需要较低的制造成本和数吨的生产能力，尤其是对于那些地理负担主要集中在中低收入国家或具有大流行潜力的传染病。对抗体和其他肠胃外蛋白质疗法的工艺经济学和制造技术的分析表明，规模经济对降低原料药生产成本的重要性。标准化的抗体生产平台流程具有很大的优势，该流程可移植到大多数现有的非常大规模的设施中，在流程转移和扩大规模过程中发生并发症的风险较低，并且具有可预测的时间表以及技术和监管的可能性成功。对于可以通过抗体（例如COVID-19或流感）治疗的具有大流行潜力的传染病，这些优势至关重要。本文受版权保护。版权所有。

本文受版权保护。版权所有。