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    • 2. 发明公开
    • A NOVEL METHOD FOR STABILIZATION OF A BIOPHARMACEUTICAL DRUG PRODUCT DURING PROCESSING
    • EP4186523A1
    • 2023-05-31
    • EP22199752.1
    • 2017-09-15
    • Leukocare AG
    • SCHOLZ, MartinKEMTER, KristinaALTRICHTER, JensKRIEHUBER, Thomas
    • A61K39/395A61K48/00C12N7/00C12N15/86
    • The present invention relates to a method of producing a biopharmaceutical drug product comprising a biomolecule of interest, the method comprising: (a) a first phase of preparing a drug substance of the biomolecule of interest, said first phase comprising at least one processing step selected from (a1 ) harvesting, (a2) purification, (a3) re-buffering, and (a4) enrichment, wherein said at least one processing step in this first phase is carried out in the presence of a composition comprising at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function, and (b) a second phase of further processing the drug substance prepared in (a) to obtain a biopharmaceutical drug product, said second phase comprising at least one processing step selected from (b1 ) re-buffering, (b2) freezing, (b3) thawing, and (b4) filling; wherein said at least one processing step in this second phase is carried out in the presence of a composition comprising (i) at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function; and (ii) one or more sugar(s); in an amino acid:sugar ratio between 10:1 to 1 :100 (w/w). The present invention further relates to a biopharmaceutical drug product obtained or obtainable by the method of the invention.