Speeding Biosimilar Development Using Glycosylation Control TechnologyIssue: June 22, 2016
| Category: Upstream
With strong growth in the biosimilars market competition is rife, as numerous companies fight to get their drug to market first and win market share. Rapid product development will be crucial, and access to advanced technologies that can accelerate development timelines will provide manufacturers with real competitive advantage. To receive approval, a biosimilar must have physicochemical/structural/functional properties that are comparable to those of the targeted branded biologic. Many peptides and proteins in mammalian cells are modified with sugar molecules. Consequently, therapeutic proteins are often subjected to glycosylation, a form of post-translational modification. The type, number and locations of sugar molecules or the glycosylation pattern, of a protein affect not only its structure and folding ability, but its stability, in vivo half-life and transportability, immunogenicity and efficacy. In a recent white paper, we discussed how careful control of glycosylation chemistry during biosimilar manufacturing is necessary to ensure optimal matching of glycosylation patterns and the ability to attain properties comparable to the targeted branded drug. Click here to read the white paper. In This Same Issue |
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