Have you found with the new poloxamer that customers don’t need to do lot to lot testing or less testing?

Answer

We have tested 100+ customer samples and have built an extensive sample library and compared our results. We could see that our conclusions are quite representative to the results our customers had with the respective material. For sure total cell densities and viabilities can differ but we are able to distinguish between good and poor performing lots. Several customers have an internal quality requirement to confirm CoA results from suppliers and have to test the incoming material with their proprietary cell line. Nevertheless it might be possible to perform reduced testing after an internal risk assessment as Merck will perform full spec testing for every batch.