If you cannot get an ELISA to work, you can rely on MS analysis under GMP conditions.
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 projects.
So what does that mean for you?
It means that there is now a plan B for developing a vaccine, recombinant protein – or cell & gene therapy, 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 your 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 sees a new pandemic and needs to develop fast and safe vaccines.