The role of glycan characterisation in ATMP development and evaluation

Abstract

AbstractAdvanced therapeutic medicinal products (ATMP) aim to transform treatment strategies for unmet clinical needs. ATMP development requires product standardisation, high‐quality consistent starting materials, and safety and efficacy, while reducing adverse reactions. Glycosylation is a common post‐translational modification of glycans to specific peptide sites. Changes in glycosylation in starting materials or culture can potentially affect the bioactivity, safety and efficacy of glycosylated products. Glycan analysis is applied to few biological products, most commonly monoclonal antibodies and glycoconjugate vaccines. Regulatory authorities are starting to scrutinise the glycan profiles of biomedical products more carefully since glycosylation‐mediated activity has been recognised to lead to adverse effects in this class of therapies, including allergic/hypersensitivity reactions, anti‐drug antibodies and product heterogeneity in biologic and advanced treatments. This review highlights the impact of glycosylation in cell and tissue substrates for use in advanced therapies, identifying the need for glycan analysis to design safer, consistent products.