Analytical Development
Analytical Development
Analytical development would include development of the basic methodologies required for demonstrating content, product related impurities (such as charge variants, aggregation) and general glycosylation profile (consisting of values for afucosylation, Galactosylation and M5+ mannosylation.
The clones would be provided with a comparative package for the glycosylation and charge variants. Additional analytical information can be opted for.