Vir Biotechnology, San Francisco, California, USA.
Biotechnol Prog. 2021 May;37(3):e3139. doi: 10.1002/btpr.3139. Epub 2021 Mar 16.
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.
目前仅有少数单克隆抗体获得批准用于治疗传染病，但针对广泛的传染病，包括埃博拉、流感、乙肝、艾滋病毒、登革热和 COVID-19，有多种产品正在开发中。单克隆抗体技术的成熟程度现在使我们能够以“大流行速度”识别和推进针对 SARS-CoV-2 的中和单克隆抗体产品进入临床，针对 SARS-CoV-2 的单克隆抗体管道已经证明了这一点。然而，要确保这些产品在全球范围内用于被动免疫，就需要低制造成本和多吨生产能力——特别是对于那些地理负担主要落在中低收入国家或有大流行潜力的传染病。对抗体和其他注射用蛋白治疗药物的工艺经济学和制造技术的分析表明，规模经济对于降低药物物质制造的商品成本非常重要。对于一种具有大流行潜力的传染病，如果可以用抗体治疗，例如 COVID-19 或流感，这种趋同的标准化平台工艺具有许多优势，它可以转移到大多数现有的大规模设施，在工艺转移和放大过程中风险低，并且具有可预测的时间表和技术及监管成功的可能性。
