WHITAKER, JOHN STEVEN,LAMBERT, WILLIAM JOSEPH,FERGUSON, KENNETH M.,DEMOPULOS, GREGORY A.
申请号：
ARP170102432
公开号：
AR109494A1
申请日:
2017.08.31
申请国别(地区):
AR
年份:
2018
代理人:
摘要：
This document deals with the high concentration and low viscosity of masp-2 inhibitors, including formulations and treatments for inhibiting the adverse effects of the activation of supplements to which masp-2 belongs. 1. Requirement 1: stable drug formula suitable for parent management of mammals, including: (a) aqueous solution, buffer system with pH value of 5.0-7.0； And (b) monoclonal antibodies, or part of them, specifically bound to human concentrations of about 50 mg / ml to about 250 mg / ml of masp-2,The antibody or fragment comprises (1) an amino acid sequence determined by SEQ ID 2 and (2) a variable light chain region composed of amino acid sequence determined by SEQ ID 3； The viscosity of the formula ranges from 2 to 50 sentinels (CPS).And the formula is stable when stored between 2 ° C and 8 ° C for at least 6 months. 38. Claim 38: the pharmaceutical formulation of claim 1, including: about 20 mM sodium citrate, about 200 mm l-argina HCl, wherein the concentration of antibody in the formula is about 175 mg / ml, about 195 mg / ml, and the viscosity is less than 25. CP. claim 40: pharmaceutical formulation of claim 1, including: approximately 20 mm L-histidine, approximately 200 mm l-argina HCl,Wherein, the concentration of antibody in the formula is about 175 mg / ml, about 195 mg / ml, and the viscosity is less than 25 mg / ml, claim 44: Pharmaceutical expression for claim 43, wherein the antibody is a full-length IgG4 human antibody. Requirement 58: a stable hydrochemical formulation suitable for parental management of mammals, substantially comprising: (a) 80 to 0.08 per cent polyurethane at concentrations between 0.01 and 0.08 per cent； and (b) aminoethanol at concentrations between 150 mm and 200 mm；(c) sodium citrate in concentrations ranging from 10 mm to about 50 mm； and (d) a monoclonal antibody or part thereof, specifically related to masp-2 humans, in concentrations ranging from about 150 mg / ml to 200 mg / ml； The antibody or fragment ther
