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PHARMACEUTICAL FORMULATIONS FOR ANTI-TNF-ALPHA ANTIBODIES
专利权人:
MABXIENCE S.A.
发明人:
BAÑADO, Carlos,BÈS, Cédric,MCGARVEY, Orla
申请号:
EPEP2016/051850
公开号:
WO2016/120413A1
申请日:
2016.01.28
申请国别(地区):
WO
年份:
2016
代理人:
摘要:
The present invention relates to aqueous stable antibody compositions suitable for long term storage, in particular comprising antibodies against Tumor Necrosis Factor alpha (anti-TNFα). More specifically, it provides an aqueous composition comprising: - an anti-TNFα antibody - a buffer selected from the list consisting of an acetate buffer, a citrate buffer, and a citrate-acetate buffer and - an excipient, wherein said excipient is at least selected from a disaccharide, a sugar alcohol and a combination thereof wherein when the buffer comprises or consists of an acetate buffer, said composition comprises a disaccharide at a concentration of less than 240 m M wherein when the buffer comprises or consists of a citrate or a citrate-acetate buffer, said composition comprises a sugar alcohol at a concentration from 50 mM to 300 mM and wherein the pH of the composition is from pH 4.0 to pH 7.0. It further relates to the pharmaceutical use of said composition, in particular in the treatment of inflammatory and immune system mediated diseases associated to an increase of TNFα.In addition, the invention relates to methods for obtaining said composition and devices comprising thereof.La présente invention concerne des compositions danticorps stables aqueuses convenant au stockage à long terme, en particulier comprenant des anticorps dirigés contre le facteur alpha de nécrose tumorale (anti-TNFα) Plus spécifiquement, elle concerne une composition aqueuse comprenant :- un anticorps anti-TNFα - un tampon sélectionné dans la liste constituée dun tampon acétate, dun tampon citrate et dun tampon citrate-acétate et - un excipient, ledit excipient étant au moins choisi parmi un disaccharide, un alcool de sucre et une combinaison de ceux-ci ladite composition comprenant, lorsque le tampon comprend ou est constitué dun tampon acétate, un disaccharide à une concentration inférieure à 240 m m ladite composition comprenant, lorsque le tampon comprend ou est constitué dun tampon citra
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