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A novel method for stabilizing biopharmaceutical products during processing
专利权人:
ロイコケア・アクチェンゲゼルシャフト
发明人:
ショルツ,マルティン,ケムター,クリスティナ,アルトリヒター,イェンス,クリーフーバー,トーマス
申请号:
JP2019514711
公开号:
JP2019537552A
申请日:
2017.09.15
申请国别(地区):
JP
年份:
2019
代理人:
摘要:
The present invention relates to a method for producing a biopharmaceutical product comprising a biomolecule of interest, said method comprising: (a) a first phase of preparing a drug substance of the biomolecule of interest, wherein said first phase comprises (a1) collecting (A2) purification, (a3) rebuffering, and (a4) enrichment, wherein said at least one processing step in said first phase comprises at least three amino acids. Carried out in the presence of a substance, wherein the combination of at least three amino acids has at least one positively charged functional group, at least one antioxidant functional group, at least one osmotic pressure regulating function, and at least one buffering function. Providing a first phase, and (b) a second phase for further processing the drug substance prepared in (a) to obtain a biopharmaceutical product, wherein said second phase comprises (b1) rebuffering; b C.) At least one processing step selected from: freezing, (b3) thawing, and (b4) filling, wherein said at least one processing step in this second phase comprises: (i) at least three amino acids; At least three amino acids, wherein the combination of at least three amino acids provides at least one positively charged functional group, at least one antioxidant functional group, at least one osmotic pressure adjusting function, and at least one buffering function; and (Ii) a second phase carried out in the presence of a composition comprising one or more sugars, wherein the ratio of amino acids to sugars is from 10: 1 to 1: 100 (w / w). The invention further relates to a biopharmaceutical product obtained or obtained by the method of the invention.本発明は目的の生体分子を含む生物医薬製品を生産する方法に関し、前記方法は(a)目的の生体分子の原薬を調製する第1相であって、前記第1相が(a1)採取、(a2)精製、(a3)再緩衝化、および(a4)濃縮から選択される少なくとも1つの処理ステップを含み、この第1相における前記少なくとも1つの処理ステップが、少なくとも3つのアミノ酸を含む組成物の存在下で行なわれ、前記少なくとも3つのアミノ酸の組合せが、少なくとも1つの正に荷電した官能基、少なくとも1つの抗酸化官能基、少なくとも1つの浸透圧調整機能、および少なくとも1つの緩衝機能を提供する、第1相、および(b)(a)で調製された原薬をさらに処理して生物医薬製品を得る第2相であって、前記第2相が(b1
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/
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