| 韩彬,樊华伟,曹萌.基于mRNA疫苗产品生产技术探讨监管检查关注要点[J].中国药事,2022,36(1):16-24 |
| 基于mRNA疫苗产品生产技术探讨监管检查关注要点 |
| Perspective of Regulatory Inspection in Consideration of Advances in mRNA Vaccine Manufacturing Technology |
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| DOI：10.16153/j.1002-7777.2022.01.003 |
| 中文关键词: 信使核糖核酸 新冠 疫苗 生产 药品生产质量管理规范 监管 |
| 英文关键词: mRNA COVID-19 vaccines manufacturing GMP regulation |
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| 中文摘要: |
| 目的：探讨提升商业化mRNA疫苗生产质量水平以降低风险、提升获益，确保疫苗生产过程符合法规要求，并推进监管领域相关标准、技术指南的完善。方法：通过分析mRNA疫苗生产技术特点， 梳理mRNA疫苗产品各个生产环节中的质量风险点，综述相关领域研究进展，并探讨mRNA疫苗生产现场监管检查的一些要点。结果与结论：mRNA疫苗生产一般包括转录模板制备、原液生产、制剂生产和灌装等步骤，其中产生抗原作用的mRNA分子一般采用体外表达系统，制剂生产一般采用脂质纳米颗粒 (LNP)技术。基于mRNA疫苗产品的固有风险、特定生产要求和工艺特征，明确应关注DNA模板的制备、场地设施条件、对RNA酶的控制、工艺杂质控制能力及质量保证程度、LNP生产稳健性、储运低温与防震能力、委托检验管理等方面的现场情况。建议尽快制定相关标准、指南细则，以包容审慎的态度在保证质量的前提下推进mRNA产业发展，提升疫苗生产全链条质量保证水平。 |
| 英文摘要: |
| Objective: To explore and improve the quality level of commercial mRNA vaccine production to reduce risks and increase benefits, ensure that the vaccine manufacture process meets the requirements of regulations, and promote the improvement of relevant standards and technical guidelines in the regulatory field. Method: By analyzing the features of mRNA vaccine manufacture technology, the quality risk points in each manufacture link of mRNA vaccine products were summarized, the research progress in related fields was reviewed, and some key points of on-site supervision and inspection for mRNA vaccine production were discussed. Results and Conclusion: The manufacture process of mRNA vaccines generally includes transcription template preparation, original solution production production, preparation and filling. The mRNA molecules producing antigenic effects are generally expressed from in-vitro transcription system, and the preparation production generally uses LNP technology. Based on the inherent risks, specific production requirements and process characteristics of mRNA vaccine products, it is clear that attention should be paid to the preparation of DNA templates, site facilities, control of RNA enzymes, process impurity control capability and quality assurance, process robustness of LNP production, low temperature storage/transportation condition and shock resistance, entrusted inspection management and other aspects of the site situation. It is suggestedthat relevant standards and guidelines be formulated as soon as possible, the development of mRNA industry be promoted inclusively and prudently on the premise of quality assurance, and the quality assurance level of the whole chain of vaccine production be improved. |
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