What to Consider when Scaling Fill/Finish for Cell & Gene Therapy?

Helge Grosch
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Abstract

Transitioning from lab manufacture to commercialization presents significant challenges, no matter what area you’re working in. Cell and gene therapies are no different and production quantities must scale at multiple stages, first to support clinical trials and then when they reach the market.
缩放单元格的填充/完成时需要考虑什么?基因疗法吗?
从实验室制造到商业化的过渡提出了重大挑战,无论你在哪个领域工作。细胞和基因疗法没有什么不同,生产数量必须在多个阶段进行扩展,首先是为了支持临床试验,然后是当它们进入市场时。
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