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Manufacture Advanced Medicine

Let’s Focus on Filtration

Gene therapies are an exciting new class of treatment that alters the genetic composition of cells to correct disease-causing mutations – offering patients new therapies for previously untreatable genetic diseases. In 2017, the FDA approved its first gene therapy; at the time of writing, there are 17 approved cell and gene therapies, with many more on the way (1).

Although the pace of discovery is promising, it is only half the battle. Without robust manufacturing processes, these therapies will remain out of reach for the vast majority of patients. Viral vectors, used to transport therapeutic genetic material into cells, must be effectively processed and purified for clinical use. Manufacturing viral vectors for rare diseases already poses challenges, even if the number of patients requiring treatment – and therefore the volume of viral vectors – is low. Therapies for more common diseases such as Alzheimer’s, which impacts at least 50 million people worldwide, would be even more challenging to manufacture (2).

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About the Authors

Morven McAlister

Senior Director of Regulatory and Validation Consultancy at Pall Biotech.


Aernout Martens

Global Product Manager Virus Filtration at Pall Biotech.

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