THIOL VARIANTS AND ANALYTICAL METHODS THEREOF

The free thiol group present in free cysteines in recombinant therapeutic antibodies are reactive to process components and generates product variants during early stages of biosimilar development. Free thiol group present on the structural motifs, especially in the complementary determining regions...

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Hauptverfasser:	CHANDINI D, Sakthi, NATARAJAN, Aishwarya, CHANDRAMOULI, Aakash, BHARADWAJ, Rajiv Pranesh, JAYARAMAN, Murali
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	CHEMISTRY INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES MEASURING METALLURGY ORGANIC CHEMISTRY PEPTIDES PHYSICS TESTING
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Beschreibung
Zusammenfassung:	The free thiol group present in free cysteines in recombinant therapeutic antibodies are reactive to process components and generates product variants during early stages of biosimilar development. Free thiol group present on the structural motifs, especially in the complementary determining regions (CDR), support maximal antigen binding capability. Product variants associated with these free thiol groups are detrimental for safety and efficacy of these therapeutic antibodies. Methods to identify and characterize various thiol variants an antibody composition is provided and an anti-IL-17A IgG1 composition having these thiol variants are described.