STABLE PH OPTIMIZED FORMULATION OF A MODIFIED ANTIBODY

• Main Authors: KESSLER, ROBERT, KENDALL, BORGMEYER, JEFFRY, R, JOHNSON, ROBERT, E, QI, HONG, ZENG, DAVID, L
• Format: Patent
• Language: English; French
• Published: 11.03.2004
• Edition: 7
• Subjects: CHEMISTRY; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; METALLURGY; ORGANIC CHEMISTRY; PEPTIDES; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention is directed to stable formulations of modified antibodies, each comprising an antibody fragment in an aqueous solution covalently attached to at least one nonproteinaceous polymer, such as @>lC(ethyleneglycol), through 0 succinimide moiety. CDP870 is an example of one such modified antibody. The formulations of the present invention include 0 buffer that maintains the solution at 0 pH of 3.5 to about 6, wherein all components of the modified antibody, including 0 succinimide ring of the succinimide moiety, are stable. La présente invention concerne des préparations stables d'anticorps modifiés, chacune comprenant un fragment d'anticorps dans une solution aqueuse, fixé de manière covalente à au moins un polymère non protéique, tel que du poly(éthylèneglycol), par l'intermédiaire d'une fraction succinimide. Le CDP870 est un exemple d'anticorps modifié. Les préparations de la présente invention comprennent un tampon qui maintient la solution à un pH compris entre 3,5 et environ 6, l'ensemble des constituants de l'anticorps modifié comprenant un noyau succinimide de la fraction succinimide, étant stables.