Protein formulation

  • US 6,267,958 B1
  • Filed: 03/14/1996
  • Issued: 07/31/2001
  • Est. Priority Date: 07/27/1995
  • Status: Expired due to Term
First Claim
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1. A stable isotonic reconstituted formulation comprising an antibody in an amount of about 50 mg/mL to about 400 mg/mL and a diluent, which reconstituted formulation has been prepared from a lyophilized mixture of the antibody and a lyoprotectant which prevents or reduces chemical or physical instability of the antibody upon lyophilization and subsequent storage, wherein the molar ratio of lyoprotectant:

  • antibody is about 100-510 mole lyoprotectant;

    1 mole of antibody, and wherein the antibody concentration in the reconstituted formulation is about 2-40 times greater than the antibody concentration in the mixture before lyophilization.

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