Martin Scholz,Kristina Kemter,Jens Altrichter,Thomas Kriehuber
申请号：
US16328061
公开号：
US20190216925A1
申请日:
2017.09.15
申请国别(地区):
US
年份:
2019
代理人:
摘要：
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 in 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.
