Heterogeneity and Variation of Innovator Biologics

Abstract

Biologics are large and complex glycoprotein molecules formed using complementary DNA vectors. The structure of biologics involves higher level protein folding and addition of glycoprotein moieties, which can be difficult to characterize and replicate. Both glycoprotein additions and 3D folding can result in heterogeneity and variation. Amino acid modifications, glycosylation, and folding patterns can differ between batches of biologics. Alterations in these glycoprotein structures canimpact the half‐life, tissue targeting, immunogenicity, degradation and activity of innovator biologics .

This article is protected by copyright. All rights reserved.

https://ift.tt/2qTIH7C