ФЕРНАНДЕС Джейсон Е. (US),ДИКСОН Дэниэль А. (US),ПАУЛСОН Андреа (US)
申请号：
RU2013104181/10
公开号：
RU2013104181A
申请日:
2013.02.01
申请国别(地区):
RU
年份:
2014
代理人:
摘要：
1. A preparation comprising: (a) a single-domain antigen binding molecule (SDAB) in a concentration of from about 0.1 mg / ml to about 350 mg / ml, containing one or more single-domain molecules, where at least one of the single-domain molecules binds to a human serum albumin (HSA)； (b) lyoprotector； and (c) a histidine buffer in a concentration of from about 5 to about 50 mM, so that the pH of the preparation is from about 5.0 to 7.5.2. The drug according to claim 1, where the histidine buffer is present in a concentration of from about 5 mm to about 50 mm, from about 5 mm to about 40 mm, from about 5 mm to about 30 mm, from about 10 mm to about 20 mm, or about 10 mM, about 20 mM, or about 30 mM. 3. The drug according to claim 1, where the pH of the drug is selected from the group consisting of 5； 5.5； 5.8-6.1； 6.0； 6.1； 6.5； 7； 7.2 and 7.5.4. The preparation according to claim 1, wherein said lyoprotector is selected from the group consisting of sugars of amino acids, methylamine, lyotropic salt, polyols, propylene glycol, polyethylene glycol, Pluronic and their combinations； said sugar is selected from the group consisting of sucrose, sorbitol and trehalose； said amino acid selected from the group consisting of monosodium glutamate and histidine； and / or said polyol is selected from the group consisting of tribasic sugar alcohols and higher sugar alcohols. 5. The preparation according to claim 4, wherein said sucrose, sorbitol or trehalose are present in a concentration of from about 2.5% to about 10%, from about 5% to about 10%, from about 5% to about 8%, or about 4%, about 4.5%, about 5%, about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, or about 9% (mass / volume) .6. The drug according to any one of claims 1 to 5, where the SDAB molecule is1. Препарат, содержащий:(а) однодоменную антигенсвязывающую молекулу (SDAB) в концентрации от примерно 0,1 мг/мл до примерно 350 мг/мл, содержащую одну или более однодоменных молекул, где по мен
