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filingDate 2020-10-02-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_b9c45ba6f4de9a758f1a8ae7f0f29d45
publicationDate 2021-01-29-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-112274636-A
titleOfInvention A stable aqueous solution composition containing recombinant fully human anti-PD-1 monoclonal antibody
abstract The invention relates to the technical field of biomedicine, in particular to a stable aqueous solution composition containing recombinant fully human anti-PD-1 monoclonal antibody, the composition comprising recombinant fully human anti-PD-1 monoclonal antibody, histidine/hydrochloric acid Histidine buffer, sucrose, sodium chloride and polysorbate 80; the purpose of this application is to provide a stable aqueous solution composition suitable for intravenous drip. Through the screening of buffer systems and excipients, various buffers, excipients and surfactants were screened and studied. The study showed that in the aqueous composition, by adding less sodium chloride, not only the reduction of sucrose, polysorbate The dosage of 80 is obtained, and a composition favorable for drug stability is also obtained. The composition of the present invention can pass the long-term stability test at 2-8°C, accelerated stability test at 25±2°C, and high-temperature stability test at 40±2°C.
priorityDate 2020-10-02-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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