Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2023-08-01 DOI:10.1016/j.biologicals.2023.101698

Sunil Gairola, Prashant Bonde, Pankaj Sharma, Sameer kale, Sunil Goel, Suresh Jadhav

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引用次数: 1

Abstract

Meningococcal A Conjugate Vaccine (MenAfriVac) is the world’s first Monovalent Conjugate Vaccine against Neisseria Meningitidis serogroup A which has obtained Controlled Temperature Chain (CTC) label claim of “stable upto 40°C for 4 days prior to reconstitution” developed by Serum Institute of India Pvt. Ltd. Pune, India and the vaccine was granted permission from World health Organization. This paper elucidates and talks about the layout of various studies performed to characterize the product to declare as CTC at the time when the knowledge and mechanism to describe CTC was not fully known which in term helped to design the CTC guidelines.

Product stability was assessed using clinical, consistency and regular lots released by NRA. The critical stability indicating parameters like free polysaccharide, molecular size distribution along with Potency and safety tests were carried out to support the product stability making sure it also qualifies for Vaccine Vial Monitor label claim of VVM30. An additional in use stability (reconstitution) was also performed. All studies indicated that the product remains stable at real time as well as elevated temperatures and well within the specifications approved by NRA and formed the strong basis for CTC claim which is now recommended by WHO.

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冻干甲型脑膜炎球菌结合疫苗(MenAfriVac™)在高温下的稳定性，以支持控制温链(CTC)的说法

脑膜炎球菌A结合疫苗（MenAfriVac）是世界上第一种针对脑膜炎奈瑟菌血清群A的单价结合疫苗，该疫苗获得了印度血清研究所（Serum Institute of India Pvt.有限公司Pune开发的“重建前4天稳定在40°C”的控制温度链（CTC）标签，印度和该疫苗获得了世界卫生组织的许可。本文阐述并讨论了在描述CTC的知识和机制尚不完全清楚的情况下，为表征要宣布为CTC的产品而进行的各种研究的布局，这在术语上有助于设计CTC指南。使用NRA发布的临床、一致性和常规批次评估产品稳定性。进行了关键稳定性指示参数，如游离多糖、分子大小分布以及效价和安全性测试，以支持产品的稳定性，确保其也符合VVM30疫苗小瓶监测标签的要求。还进行了额外的使用稳定性（重构）。所有研究表明，该产品在高温下实时保持稳定，完全符合NRA批准的规范，并为世界卫生组织现在建议的CTC声明奠定了坚实的基础。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.

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