| abstract |
Recombinant hTNFα antibody suitable for blocking or counteracting hTNFα activity, comprising a therapeutically effective amount of antibody in a buffer and having a storage period of at least 18 months. The components of the buffer include mannitol, citric acid monohydrate, sodium citrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate, and water. Prepare a buffer solution and adjust the pH of the solution with aqueous sodium hydroxide solution. The order of addition of buffer components is not critical and can be selected arbitrarily. A liquid aqueous pharmaceutical formulation with a pH of 4-8, a shelf life of 18 months and remains stable after at least 3 freeze / answer cycles. [Selection figure] None |