Why glycosylation control is no longer a secondary concern in the development of complex biologics
In an article in Genetic Engineering & Biotechnology News (GEN), Sojeong Lee, Director of Upstream Development, highlights why glycosylation control has shifted from a downstream adjustment to an early-stage upstream priority. Next-generation modalities, such as bispecific antibodies and ADCs, are highly sensitive to glycan heterogeneity, which directly impacts safety and efficacy. Because 80% of glycan variation is clone-dependent, implementing high-throughput screening, Quality-by-Design (QbD) principles, and robust statistical models during early development is essential to minimize clinical and regulatory risks.
Read the full article in GEN to explore our upstream development methodologies.
In an article in Genetic Engineering & Biotechnology News (GEN), Sojeong Lee, Director of Upstream Development, highlights why glycosylation control has shifted from a downstream adjustment to an early-stage upstream priority. Next-generation modalities, such as bispecific antibodies and ADCs, are highly sensitive to glycan heterogeneity, which directly impacts safety and efficacy. Because 80% of glycan variation is clone-dependent, implementing high-throughput screening, Quality-by-Design (QbD) principles, and robust statistical models during early development is essential to minimize clinical and regulatory risks.
Read the full article in GEN to explore our upstream development methodologies.
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