12 BioPharm International eBook October 2018 www.biopharminternational.com
Biopharma Laboratory Best Practices Glycan Analysis
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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