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发展中国家疫苗制造商的技术能力对全球免疫接种具有重要意义。

Developing-country vaccine manufacturers' technical capabilities can make a difference in global immunization.

机构信息

DCVMN International, Route de Crassier 7, 1262 Nyon, Switzerland.

Quality Assist, Cape Town, South Africa.

出版信息

Vaccine. 2021 Aug 23;39(36):5153-5161. doi: 10.1016/j.vaccine.2021.07.044. Epub 2021 Aug 3.

Abstract

Members of the Developing Countries Vaccine Manufacturers' Network (DCVMN) have been actively engaged in the development of COVID-19 vaccine candidates. According to the WHO COVID-19 vaccine landscape updated on 29 December 2020, 18 member manufacturers had vaccines in preclinical or clinical trials, including three members with candidates in Phase III trials. Once successful candidates have been identified there will be a need for large scale vaccine manufacturing and supply, in which DCVMN member manufacturers can play a key role. In an internal survey in 2019, DCVMN members reported the capability to supply over 3.5 billion vaccine doses annually, and the provision of over 50 distinct vaccines to 170 countries. To describe the capabilities of DCVMN member manufacturers more precisely, a 121-question survey was circulated to 41 Network members. The survey assessed the manufacturers' capabilities in utilizing various technology platforms, cell cultures and filling technologies, in addition to their capacities for manufacturing drug products. The survey also evaluated manufacturers' preparedness to dedicate existing capacities to COVID-19 vaccine production. Results revealed that sampled manufacturers have strong capabilities for manufacturing vaccines based on recombinant technologies, particularly with mammalian cells, and microbial and yeast expression systems. Capabilities in utilizing cell cultures were distributed across multiple cell types, however manufacturing capacities with Vero and CHO cells were prominent. Formulating and filling findings illustrated further large-scale capabilities of Network members. Sampled manufacturers reported that over 50% of their capacity for vaccine manufacturing could be dedicated to COVID-19 vaccine production.

摘要

发展中国家疫苗制造商网络(DCVMN)的成员一直在积极参与 COVID-19 疫苗候选物的开发。根据世界卫生组织(WHO)2020 年 12 月 29 日更新的 COVID-19 疫苗情况,已有 18 家成员制造商的疫苗处于临床前或临床试验阶段,其中 3 家有候选疫苗进入第三阶段试验。一旦确定了成功的候选疫苗,就需要大规模的疫苗生产和供应,DCVMN 成员制造商可以在其中发挥关键作用。在 2019 年的一项内部调查中,DCVMN 成员报告称,他们每年有能力供应超过 35 亿剂疫苗,并向 170 个国家提供超过 50 种不同的疫苗。为了更准确地描述 DCVMN 成员制造商的能力,向 41 个网络成员分发了一份包含 121 个问题的调查。该调查评估了制造商在利用各种技术平台、细胞培养和灌装技术方面的能力,以及他们生产药物产品的能力。该调查还评估了制造商为将现有产能专门用于 COVID-19 疫苗生产而做好准备的情况。结果表明,抽样制造商在基于重组技术制造疫苗方面具有强大的能力,特别是使用哺乳动物细胞和微生物及酵母表达系统。细胞培养方面的能力分布在多种细胞类型中,但 Vero 和 CHO 细胞的制造能力较为突出。配方和灌装结果进一步说明了网络成员的大规模能力。抽样制造商报告称,他们超过 50%的疫苗生产能力可专门用于 COVID-19 疫苗生产。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e754/8330991/0618356a31ed/gr1_lrg.jpg

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