CALLAHAN, William,REMMELE, Richard L.,RATNASWAMY, Gayathri,LATYPOV, Ramil F.,LIU, Dingjiang
申请号:
ES07775901
公开号:
ES2599318T3
申请日:
2007.04.20
申请国别(地区):
ES
年份:
2017
代理人:
摘要:
Lyophilized peptide body composition comprising a buffer, a loading agent, a stabilizing agent and a surfactant; wherein said buffer is composed of a pH buffering agent, wherein: a) said pH buffering agent is 10 mM histidine and the pH is 5.0; said filler is 4% w / v mannitol; said stabilizing agent is 2% w / v sucrose; and said surfactant is 0.004% w / v polysorbate 20; or b) said pH buffering agent is 10 mM histidine and the pH is 7.0; said filler is 4% w / v mannitol; said stabilizing agent is 2% w / v sucrose; and said surfactant is 0.01% w / v polysorbate 20; or c) said pH buffering agent is 10 mM histidine and the pH is 5.0; said filler is 2.5% w / v mannitol; and said stabilizing agent is 3.5% w / v sucrose; or d) said pH buffering agent is 10 mM histidine and the pH is 4.5; said filler is 4% w / v mannitol; said stabilizing agent is 2% w / v sucrose; and said surfactant is 0.004% w / v polysorbate 20; or e) said pH buffering agent is 20 mM histidine and the pH is 5.0; said filler is 4.0% w / v mannitol; and said stabilizing agent is 2.0% w / v sucrose; and wherein said peptibody comprises a structure set forth in formula I, Formula I: [(X1) a-F1- (X2) b] - (L1) c-WSPd in which: F1 is an Fc domain; X1 is selected from: P1- (L2) e- P2- (L3) f -P1- (L2) e- P3- (L4) g-P2- (L3) f -P1- (L230) e- and P4- (L5) h-P3- (L4) g-P2- (L3) f-P1- (L2) e; X2 is selected from: - (L2) e-P1, - (L2) e-P1- (L3) f-P2, - (L2) e-P1- (L3) f-P2- (L4) g-P3, and - (L2) e-P1- (L3) f-P2- (L4) g-P3- (L5) h-P4; wherein P1, P2, P3 and P4 are each independently pharmacologically active peptide sequences; L1, L2, L3, L4 and L5 are each independently union groups; a, b, c, e, f, g and h are each independently 0 or 1, with the proviso that at least one of a and b is 1; d is 0, 1 or greater than 1; and WSP is a water soluble polymer, the union of which is made in any reactive moiety in F1.Composicion de pepticuerpos liofilizada que comprende un tampon, un agente de carga, un agente estabilizante y