A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 39/00 (2006.01) C07K 16/00 (2006.01)
Patent
CA 2615122
The present invention provides an immunoconjugate formulation that is substantially free of particles, the immunoconjugate formulation comprising: an immunoconjugate and one or more excipients selected from the group consisting of: sucrose, polysorbate 20, polysorbate 80, cyclodextrin, dextrose, glycerol, polyethylene glycol, mannitol, sodium chloride, and an amino acid, wherein the formulation is a buffered aqueous solution having a pH of 4.5 to 7.6. The present invention also provides an immunoconjugate formulation that is substantially free of aggregates, the immunoconjugate formulation comprising: an immunoconjugate and one or more excipients selected from the group consisting of histidine, sucrose, glycine and sodium chloride, wherein the formulation is a buffered aqueous solution having a pH of 4.5 to 7.6. The present invention further provides an immunoconjugate formulation that is substantially free of both particles and aggregates.
L'invention concerne une formulation d'immunoconjugué sensiblement exempte de particules qui contient : un immunoconjugué et un ou plusieurs excipients choisis dans le groupe constitué de : sucrose ; polysorbate 20 ; polysorbate 80 ; cyclodextrine ; dextrose ; glycérol ; polyéthylèneglycol ; mannitol ; chlorure de sodium ; et un acide aminé. La formulation est une solution aqueuse tamponnée d'un pH de 4,5 à 7,6. L'invention concerne également une formulation d'immunoconjugué sensiblement exempte d'agrégats qui contient : un immunoconjugué et un ou plusieurs excipients choisis dans le groupe constitué de : histidine ; sucrose ; glycine ; et chlorure de sodium. La formulation est une solution aqueuse tamponnée d'un pH de 4,5 à 7,6. L'invention concerne enfin une formulation d'immunoconjugué sensiblement exempte aussi bien de particules que d'agrégats.
Amphlett Godfrey
Bartlett Elizabeth
Chih Hung-Wei
Fleming Michael S.
Zhang Wei
Gowling Lafleur Henderson Llp
Immunogen Inc.
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