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Preparation of factor IX Lyophilized vial, Kit, and Method for producing a Powder
专利权人:
BIOGEN IDEC MA INC.
发明人:
申请号:
ARP150100880
公开号:
AR099838A1
申请日:
2015.03.25
申请国别(地区):
AR
年份:
2016
代理人:
摘要:
Claim 1: pre lyophilization formulation comprising: (a) a polypeptide of factor IX (FIX) which Fix coagulation activity; (b) a buffering agent; (c) a Stabilizing Agent, a Thickening agent; (d) and (e) a Surfactant, where the formulation has a volume of Filling less than about 5 mlLess than about 4 ml or less than about 3 ml, and where each of (a) - (e) are in an amount per vial (mg / vial) sufficient to permit better stability of polypeptide (1) fix the lyophilised; (2) the reconstitution of lyophilised less time; (3) Minor splashes sob Re a Stopper which comprises the formulation; (4) less time of freeze-drying cycle; (5) Greater useful LifeIl a freeze-dried formulation prepared from pre freeze drying at room temperature (6); or any combination of these, compared with a pre lyophilization formulation of reference where the reference formulation comprises (a) - (e) an identical amount per vial The pre lyophilization formulation, but has a volume of 5 ml of filling.Claim 26: a pre lyophilization formulation comprising: (a) about 80 to about 3000 IU / ml of rfixfc; (b) about 7.76 mg / ml of l-histidine; (c) about 47.6 mg / ml of mannitol; (d) around 23.8 mg / ml sucrose; and (e) of about 0.2 mg / ml Polysorbate - 2 0.29: a claim that freeze-drying Powder, from the pre lyophilization formulation of any of claims 1 to 28.Claim 88: a method for producing a Powder comprising a polypeptide of fixComprising: (a) a step of Frozen Freeze that includes a pre lyophilization formulation comprising a polypeptide of fix reducing temperature for about 2 hours at a temperature of Frozen Around - 55C and keeping the temperature of Frozen during the Around 2 p.m.; (a) comprising a step of Tempered increase for around 1,5 hours the temperature of Frozen pre lyophilization formulation of Step (a) to a Tempering temperature Around - 6 c, keeping the temperature quenching for around 3 hours and reduce the temperature for around 1,5 hours to around - 55C; (b) a step of Vacuum freeze-
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