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