Viral clearance process

Details Viral clearance process Viral clearance process

C - Chemistry, Metallurgy

07

K

C07K 1/00 (2006.01) A23J 1/00 (2006.01) A61L 2/00 (2006.01) C07K 14/00 (2006.01) C07K 16/00 (2006.01) C07K 16/06 (2006.01) C07K 16/34 (2006.01) C07K 17/00 (2006.01)

Patent

CA 2306181

Methods for producing immunoglobulins and in particular anti-D immunoglobulin substantially free of virus and product resulting therefrom. Specifically provided are methods for nanofiltration of the anti-D immunoglobulin in high ionic strength buffer and with excipient such as polysorbate 80. Additional steps include diafiltration to concentrate the anti-D protein and reduce the concentration of excipient present.

L'invention concerne des procédés de production d'immunoglobulines et notamment d'immunoglobuline anti-D sensiblement exempte de virus, de même que le produit ainsi obtenu. L'invention porte plus particulièrement sur des procédés de nanofiltration de l'immunoglobuline anti-D placée dans une solution tampon possédant une force ionique élevée et contenant un excipient tel que le polysorbate 80. Des étapes supplémentaires comprennent une étape de diafiltration destinée à obtenir une concentration supérieure de la protéine anti-D et à réduire la teneur de l'excipient présent.

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