Reagents Matter – Osmolality Testing in Gene Therapy Manufacturing

BPI Contributor

October 6, 2021

2 Min Read
Reagents Matter – Osmolality Testing in Gene Therapy Manufacturing

Osmolality testing provides a versatile measure of solute concentration that is an important consideration in the manufacture of gene therapies. This white paper discusses how monitoring osmolality of media during upstream viral vector production and reagents during downstream purification processes can influence quality of the final product. The dependence of multiple biological processes on osmolality, coupled with the usefulness of its measurement in vector quality control, means that osmolality testing is a powerful method to support a high yield of safe and effective gene therapy products.

A case study included in the white paper explores the benefits of osmolality testing for biopharmaceutical manufacture and explains how this data can be used to optimize buffers used for gene therapy manufacturing. As well as describing the rationale and analytical techniques used, this article also presents data from the process, giving you deeper insight into how rapid custom reagent formulation was achieved.


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