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AssigneeGenmab A/S
InventorsRichard G. HIBBERT, Bolette BJERREGAARD, Søren S. JENSEN, César F. OLIVEIRA DA COSTA, Rohan O'DONNELL, Sipke SANGERS, Muriel VAN KAMPEN
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The present disclosure provides highly purified epcoritamab compositions, which comprise a bispecific antibody that binds CD3 and CD20. In the highly purified compositions, impurities, such as epcoritamab protein variants, process-related impurities and/or product-related impurities, have been minimized or removed. Methods of preparing the highly purified epcoritamab compositions are also provided.
A composition comprising at least 95% epcoritamab and less than 5% of an impurity.
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A composition comprising at least 95% epcoritamab and less than 5% of an acidic epcoritamab variant that is deamidated at residues N103 and N106 of CD3 heavy chain of epcoritamab.
A composition comprising at least 95% epcoritamab and less than 5% of a high molecular weight species (HMWS) of epcoritamab, wherein the HMWS is an epcoritamab dimer comprising a signal sequence having the amino acid sequence shown in SEQ ID NO:
A composition comprising at least 95% epcoritamab and less than 5% of a low molecular weight species (LMWS) of epcoritamab, wherein the LMWS is an Fc+Fab fragment of epcoritamab.
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Dependencies are inferred from the claim text.