The world’s first GMP-certified MS-based HCP analysis is now a reality

Rely on MS analysis under GMP conditions when your ELISA's not working

Last week, Alphalyse received our GMP certificate, officially stating that we are approved for performing quality control of biological API. So now we can set up validated mass spectrometry assays for analyzing residual impurities / Host Cell Proteins using our unique method based on 250 client HCP projects.

So what does that mean for biotech companies?

It means that there is now a plan B for developing a vaccine, recombinant protein – or cell & gene therapy, for instance, when:

• There are problems with your ELISA – or you cannot find an ELISA at all.
• Using E. coli, HEK, SF9, or CHO ELISA kits – and the supplier runs out of antibodies.
• You use a unique expression system and have no time to develop a custom ELISA – or in any situation with time restraints.
• It would help if you had a better tool for your process development – and want to ensure it can be validated and used for the release test once you get there.
• The world is seeing a new pandemic and needs to develop fast and safe vaccines.

This achievement marks a shift in the way MS-based HCP analysis can be utilized, now making it available for marketed products.

If you would like to know more about how we qualified the method for GMP, you may want to watch a short webinar on the topic, held by Thomas Kofoed: