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.

About TEKNOVA

Consider us your potion masters. You’re seeking to unlock the potential of new medicines and therapies that will better our world. Now you need support that will help you make your magic, not hold you back. We’ve made ourselves an agile, supportive, and responsive provider of life science products and services so we can equip you with exactly the right solution at exactly the right time.

As a trusted manufacturer of custom gene therapy reagents, we at Teknova have expertise in a wide range of analytical techniques and a deep understanding GMP and RUO standards for bioprocessing and bioproduction reagents.

  • Have a unique need? We’re experts in custom formulation, dispense, and QC, with flexibility to fulfill complex manufacturing requirements.
  • Have an impossible deadline? We offer exceptionally fast delivery for custom RUO and GMP products—count weeks, not months.
  • Have stringent requirements? We’re devoted to quality, from raw materials to finished goods, with all manufacturing done under ISO 13485.

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