期刊
PHARMACEUTICALS
卷 14, 期 9, 页码 -出版社
MDPI
DOI: 10.3390/ph14090934
关键词
manufacturing; bacteriophage; cell line development; upstream processing; downstream processing; drug substance; drug product
This article provides an overview of the process and challenges of phage manufacturing, including cell line development, upstream and downstream processing, as well as the additional opportunities presented by engineered bacteriophages.
Within this first part of the two-part series on phage manufacturing, we will give an overview of the process leading to bacteriophages as a drug substance, before covering the formulation into a drug product in the second part. The principal goal is to provide the reader with a comprehensive framework of the challenges and opportunities that present themselves when developing manufacturing processes for bacteriophage-based products. We will examine cell line development for manufacture, upstream and downstream processes, while also covering the additional opportunities that engineered bacteriophages present.
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