News
Qualified LC-MS method for quantifying host cell proteins in a
Bavarian Nordic A/S vaccine candidate
January 27, 2025
Alphalyse has developed and qualified an LC-MS method for monitoring host cell proteins in an MVA-BN® platform vaccine candidate on behalf of Bavarian Nordic A/S.
Bavarian Nordic is advancing the development of a vaccine to address the unmet need for protection against Western, Eastern, and Venezuelan equine encephalitis viruses (MVA-BN WEV). Bavarian Nordic opted for LC-MS analysis over traditional immunoassays to identify and quantify process-related impurities to accommodate the accelerated project timeline and the complex protein profile of a viral-based vaccine product.
The Alphalyse LC-MS method has been qualified according to the parameters in ICH Q2(R1) Validation of Analytical Procedures to demonstrate its suitability as a quantitative impurity test for control and documentation of host cell proteins in MVA-BN WEV samples for clinical phase 2. The method offers high sensitivity and reproducibility, making it particularly well-suited for quality-controlled analytics.
This is another example of how the Alphalyse LC-MS method can be qualified according to ICH guidelines while significantly expediting the release of new vaccines.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing, and commercialization of life-saving vaccines. They are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is also approved in Europe and Canada. The commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis.
Using a live virus vaccine platform technology, MVA-BN®, Bavarian Nordic has created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. For more information visit www.bavarian-nordic.com.
For more information, please contact
Thomas Kofoed, CEO, Alphalyse
Phone: +45 6310 6501
US office: (650) 543-3193
Email: kofoed@alphalyse.com

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