Change in purity method of recombinant MedixAntigens™
The quality control analysis for most of the MedixAntigens will be further improved by changing the gel electrophoresis (SDS-PAGE) method to a sensitive and accurate capillary electrophoresis (CE-SDS) method. The CE-SDS (“IgG Purity”) has been used as quality control method for MedixMAB antibodies for over 10 years and it will be applied to MedixAntigens from November 2020 onwards.
MedixAntigen products and their production processes will remain the same. The new CE-SDS purity method has been validated also for antigens. The acceptance criteria for the production lots will remain the same. This change will not affect the performance of the antigens.
What will change
The purity information on Product Specifications will change. SDS-PAGE picture will be replaced with the new capillary electrophoresis (CE-SDS) graph. At the same time, the template of Product Specifications will be updated to match our latest visual identity.