Viral clearance process

Viral clearance process

  • CN 1,576,281 B
  • Filed: 10/14/1998
  • Issued: 08/08/2012
  • Est. Priority Date: 10/14/1997
  • Status: Active Grant
First Claim
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1. virus-free anti-D immunoglobulin preparation by the preparation of following method, said method comprises:

  • (a) will separate from the immunoglobulin components that contains anti-D immunoglobulin of human plasma is that 150mM+/-20%, pH are that the damping fluid of 6.3-6.5 mixes with containing 15-24ppm polysorbate 80 and ionic strength;

    (b) smaller or equal to the supermicro filtration membrane of 30nm mixture is carried out hyperfiltration with the nominal pore size;

    (c) filtered solution of collection hyperfiltration, said filtered solution contains anti-D immunoglobulin,The pH of said preparation is 6.3-6.4, and protein contnt is 4.0-6.0%, and the content of thiomersal(ate) is 24-36ppm, and the content of polysorbate 80 is 80-200ppm, and methanol content is less than 50ppm.

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