利用下一代测序应用,从核酸基产品的身份到纯度分析
Rucha Wadapurkar1, Swarda Deo1, Renuka Khanzode1
1Gennova Biopharmaceuticals Ltd., ITBT Park, Hinjawadi Phase 2 Rd, Hinjewadi Rajiv Gandhi Infotech Park, Hinjawadi, Pune 411057, India.
Pharmaceutics
|January 25, 2025
概括
下一代测序 (NGS) 提供了一种可靠的方法来评估基于核酸的产品 (NAP) 的纯度,包括mRNA疫苗和等离子体DNA. 这种方法提高了质量控制,并有助于优化这些先进疗法的制造工艺.
科学领域:
- 生物技术是生物技术.
- 分子生物学分子生物学
- 基因组学就是基因组学.
背景情况:
- 基于核酸的产品 (NAP) 是一个不断扩大的疗法类别,提供更安全的替代品.
- 国家计划的质量控制和监管框架仍在不断发展.
- 下一代测序 (NGS) 对于NAP的身份测试和杂质分析至关重要.
研究的目的:
- 开发和验证基于NGS的工作流程,以评估NAP的纯度.
- 评估NGS对mRNA疫苗和等离子体DNA的关键质量属性的应用.
- 为了识别基于核酸的杂质,并使用NGS评估序列标识.
主要方法:
- 使用短读Illumina NGS进行NAP的纯度评估.
- 将数据分析工作流应用于mRNA疫苗和等离子体DNA样本.
- 量化序列标识,DNA/RNA污染,非目标RNA和多A计数.
主要成果:
- 拟议的NGS工作流准确预测了mRNA疫苗和等离子体DNA的关键质量控制.
- 确定了基于核酸的杂质,并确认了序列的身份.
- 国家统计系统数据分析为NAP制造过程优化提供了战略决策的便利.
结论:
- 建议监管机构采用NGS数据来识别NAP中的基于核酸的杂质.
- 建议在目前的良好制造实践 (cGMP) 下审议NGS适应.
- 强调需要在整个NGS工作流程中进行方法资格和验证,从样本采集到数据分析.
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