病毒载体上游工艺流程

突破性新基因疗法的病毒载体不断增多，进一步加剧了复杂性。由于无法利用现成的工艺模板，生产商不得不压缩项目进度，高效完成原料、细胞培养基制备等上游决策。如果没有适当的风险规避措施，决策不当可能会导致严重的不可逆后果。

此类决策涉及的关键领域通常包括：

为最大限度降低这些环环相扣的工艺的波动和风险，基因疗法生产商往往会依赖于资深的生物制药合作伙伴来提供一系列专业技术、产品、工艺模式及服务。

工作流程

The rise of gene therapies is driving rapid innovation, but manufacturers face complex challenges bringing new therapies to life

Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs

Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise

Critical biosafety testing and characterization of viral vector products can help mitigate safety concerns and increase product understanding

CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization