UV-C Inactivation: A new viral inactivation method for biopharmaceuticals

Kate Bergmann, Ph.D., Eurofins Lancaster Laboratories, kbergmann@lancasterlabs.com

Viral clearance studies are performed for biopharmaceutical products to ensure that any virus that might be present in the starting material is removed and/or inactivated during purification. The majority of industry contamination events have historically been due to non-enveloped viruses (viruses that have no lipid envelope). Since these viruses can be difficult to inactivate, there is a need for an inactivation step that is effective on such viruses.

In collaboration with Sartorius-Stedim Biotech, Inc, Eurofins Lancaster Laboratories, Inc. scientists have been evaluating the effectiveness of UV-C treatment for inactivation of viruses. UV-C treatment at 254 nm targets primarily nucleic acids rather than proteins, so it should inactivate viruses while sparing the product.

UV-C treatment is most effective against parvoviruses such as Murine Minute Virus (MMV). This is important, as MMV is very difficult to inactivate and has been found in bioreactors a number of times over the last 20 years. Other virus families show lower inactivation that varies from family to family. The inactivation is consistent over a variety of conditions. UV-C treatment does cause product aggregation; however, typically the aggregates can be removed by subsequent purification steps.

This technology is simple to integrate into a purification process, as it operates in flowthrough mode and has a very limited number of critical process parameters. We see several ways in which this new technology can be useful in assuring that viruses are not present in the final product:

• Raw materials can be treated by UV-C before they enter the bioreactor. The materials are not generally affected by UV-C, so the dose applied can be high.
• UV-C treatment can be a useful addition to a purification process for "difficult" products where it is challenging to achieve sufficient viral clearance
• UV-C treatment can be used to replace a more complicated purification step (such as chromatography). This may allow simplification of the purification process and save costs as well as time.

For more information on how this technology can help you to achieve your viral clearance goals, visit www.LancasterLabsPharm.com.