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BioPharm October eBook: Best Practices 2018

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12 BioPharm International eBook October 2018 www.biopharminternational.com Biopharma Laboratory Best Practices Glycan Analysis djama\Adobe.com Glycan Analysis Best Practices Experts discuss best practices for performing glycan analysis. B ioPh ar m Inte r n at ion al sp oke w it h A le d Jones, sen ior produc t a nd appl icat ions manager at ProZyme; Philip Widdowson, Eu ropea n applicat ion development sc i- ent ist at T her mo Fisher Sc ient if ic; a nd Dr Daryl Fernandes, chief executive at Ludger Ltd, about best practices for performing glycan analysis. CHALLENGES IN GLYCAN ANALYSIS BioPharm: What are the specific challenges associated with glycoproteins in biopharmaceuticals? Jones (ProZyme): The challenge is to characterize and control the glycoforms you are making, and to under- stand the effect of these glycoforms on clinical efficacy and safety, particularly if glycosylation is known to be a critical quality attribute (CQA). As [monoclonal antibod- ies] account for over half the biopharmaceutical market, the most well-known example of biopharmaceutical gly- cosylation is N-glycosylation of IgG in the Fc region. Fernandes (Ludger): Glycosylation poses three main challenges. The first is heterogeneity. This arises through forma- tion of glycoforms. These are drug isoforms with identical protein backbones but different glycan decorations. Each glycoform has its own safety and efficacy profile so the final vial contains, not a single homogeneous product, but a mixture of many drugs. The next problem is variability. This stems from the difficulty in controlling the glycoform distributions of some biopharmaceuticals and affects consistency, both from batch-to-batch and throughout the entire product lifecycle. The third issue is complexity. Glycans cause three main types of this. The first is the large increase in structural and functional complexity resulting from SUSAN HAIGNEY

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