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Methods of manufacturing stable aqueous formulations of adalimumab

  • US 10,286,072 B2
  • Filed: 10/10/2017
  • Issued: 05/14/2019
  • Est. Priority Date: 09/07/2012
  • Status: Active Grant
First Claim
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1. A method of manufacturing an aqueous adalimumab formulation, wherein:

  • the aqueous adalimumab formulation comprises;

    (i) adalimumab;

    (ii) buffer; and

    (iii) stabilizer; and

    wherein the formulation is free of polyol, has a pH of about 5 to about 6, and is stable for one week at 40°

    C. or two weeks at 25°

    C., andthe method comprises (a) creating a formulation buffer comprising the buffer of the aqueous adalimumab formulation; and

    (b) contacting a solution comprising adalimumab with the formulation buffer.

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