KEMTER, Kristina,SCHOLZ, Martin,ALTRICHTER, Jens,KRIEHUBER, Thomas
申请号：
EPEP2017/073374
公开号：
WO2018/050874A1
申请日:
2017.09.15
申请国别(地区):
EP
年份:
2018
代理人:
摘要：
The present invention relates to a method of producing a liquid 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 liquid 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 liquid biopharmaceutical drug product obtained or obtainable by the method of the invention.La présente invention concerne un procédé de production d'un produit médicamenteux biopharmaceutique liquide, comprenant une biomolécule d'intérêt, le procédé comprenant : (a) une première phase de préparation d'une substance médicamenteuse de la biomolécule d'intérêt, ladite première phase comprenant au moins une étape de transformation sélectionnée
