ARMSTRONG, Nicholas J.,BOWEN, Mayumi N.,MAA, Yuh-Fun
申请号：
AU2020204588
公开号：
AU2020204588A1
申请日:
2020.07.09
申请国别(地区):
AU
年份:
2020
代理人:
摘要：
#$%^&*AU2020204588A120200730.pdf#####Abstract The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscocity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation. 12452950_1(GHMatters) P98606.AU.21/10 M Spray-dried Trastuzumab 0.0 0 Freeze-dried Trastuzumab Spray-dried Bevacizumab -1.0 0Freeze-dried Bevacizurnab o -2.0 -3.0 Se o -4.0 00 2 -5.0 -6.0 ~N60 -7.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Time (months) FG.1` O Bevacizumab Suspension (Pilot Scale) * Bevacizumab Suspension (Bench-Top) o Trastuzurmab Suspension (Pilot Scale) * Trastuzurnab Suspension (Bench-Top) A Rituximab Suspension (Pilot Scale) 250 A Rituximab Suspension (Bench-Top) - - - Theoretical Fitting of Equation 4 o Bevacizunab Liquid 200 0 Trastuzurnab Liquid a Rituximab Liquid Empirical Fitting 03 150 A-- - - - - - - - - -100 0 y=.2464e 1 2 0 0 50 100 150 200 250 300 mAb Concentration (mg/mL) FIG. 2A
