mRNA / LNP 生物工艺解决方案

基于 mRNA 的疫苗在应对 COVID-19 疫情方面卓有成效，mRNA 技术如今正处于改变医学世界的最前沿。临床试验从未间断，开发治疗传染性疾病甚至癌症的疫苗和疗法。

按解决方案分类按单元操作分类按产品分类

信使 RNA (mRNA) 治疗的开发和生产受到低工艺产量和可扩展性挑战的影响。基于含脂质纳米颗粒 (LNP) 的 mRNA 的疫苗是前景广阔的新平台，在许多动物研究中已经证实，它具有高蛋白质表达、稳定的免疫反应和功效。质粒 DNA (pDNA) 是 mRNA 的关键再递送模板。

Repligen 提供的各种解决方案由基因治疗、溶瘤及疫苗行业知名专家提供实践工艺和实施咨询，有助于克服 mRNA/LNP 以及 pDNA 生产中存在的关键挑战。

pDNA 工作流程

咨询专家

mRNA 生物工艺工作流程

点击工作流程链接，查看可立即实施的生产率及产量解决方案。
Repligen 工作流程解决方案包括硬件、软件和耗材，可从工艺开发扩展到大规模 GMP 生产水平。

挑战

全球需求旺盛

可扩展性和成本效益
加快上市速度
剪切灵敏度
生产率和纯化产量低

产品质量和纯度

去除 rDNA、dsRNA、RNA 片段、未包封的 LNP

工艺知识有限

有限的规模放大工艺和实施经验
缺乏对细胞和无细胞平台的在线工艺监测

Repligen 解决方案

产量提高

优化的载体生产 - 通过用微滤 TFF 代替离心，简化生产工艺
完全可扩展的层析和 TFF 设备专为低剪切和低滞留体积性能而设计，可最大程度提高产品纯度和回收率

质量提升

具有一次性使用流路的完全无菌和封闭式自动化系统
预装柱可实现始终如一的纯化和工艺
在线分析技术

专家咨询

由基因治疗、溶瘤及疫苗行业知名专家提供的
实践工艺和实施方法

Effective dsRNA Removal for Safer mRNA Therapeutics

The rapid growth of nucleic acid therapeutics, such as mRNA vaccines and therapies, has introduced transformative advancements in medicine. A critical obstacle in their production is the presence of double-stranded RNA (dsRNA) impurities. These impurities can activate immune responses, compromise therapeutic safety, and reduce efficacy. Therefore, achieving efficient dsRNA removal is vital to delivering high-quality, effective RNA-based products.

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