Pharmaceutical composition of f(ab)2 fragments of antibodies...

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) C07K 16/06 (2006.01) C07K 16/18 (2006.01) C07K 16/24 (2006.01)

Patent

CA 2443391

The invention relates to a pharmaceutical composition comprising F(ab)2 fragments of antibodies, which are preferably free of albumin and complete antibodies and substantially pryrogen-free, and an effective amount of a pharmaceutically acceptable carrier. The invention also relates to a method for the preparation of a pharmaceutical composition comprising F(ab)2 fragments of antibodies, using blood serum or plasma of a previously vaccinated mammal as source of antibodies. The blood serum or plasma is digested with an enzyme (pepsin), after which separation and purification are carried out until the pharmaceutical composition of F(ab)2 is free of albumin and complete antibodies and substantially pyrogen-free..

La présente invention concerne une composition pharmaceutique comprenant des fragments F(ab)¿2? d'anticorps, de préférence sans albumine et sans anticorps complets et également sensiblement sans pyrogènes, et une quantité efficace d'un excipient acceptable d'un point de vue pharmaceutique. L'invention concerne également un procédé de préparation d'une composition pharmaceutique comprenant des fragments F(ab)¿2? d'anticorps, consistant à utiliser le sérum ou plasma sanguin d'un mammifère préalablement immunisé comme source d'anticorps. Le sérum ou plasma sanguin est digéré à l'aide d'une enzyme, la pepsine, avant de procéder à la séparation et à la purification jusqu'à ce que la composition pharmaceutique des fragments F(ab)¿2? ne contienne plus d'albumine ni d'anticorps complets, et sensiblement pas de pyrogènes.

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