Preparation of immunoglobulin
OwnerHannu Veli Herman Suomela, Eero Olavi Hamalaineninventors
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Abstract
The invention relates to a method for producing an immunoglobulin G preparation. In the method of blood fraction containing immunoglobulin is treated 60-72 hours with mild pepsin at a pH of about 4.4, treated by the S/D virus activation method and cleared of chemicals, pepsin and decomposition products. In addition, it can be filtered with a filter with perforations of about 35 nm at maximum. According to the invention, there are obtained extremely pure and well tolerated, virally safe products.
Claims10
A method for producing an immunoglobulin G preparation from an immunoglobulin G fraction isolated from blood, characterized in that
- in order to eliminate anticomplementarity and inactivate viruses, the fraction is treated with pepsin at pH 3.8-4.6,
- whereafter the fraction is treated with the solvent/detergent virus inactivation method in order to inactivate viruses,
- whereafter the chemicals, pepsin and immunoglobulin decomposition products used in the virus inactivation are removed, and that
- in addition to this, at some stage and advantageously after the pepsin treatment, most advantageously also after the removal of the chemicals, pepsin and immunoglobulin decomposition products used for virus inactivation, the fraction is filtered through a perforated filter with perforations no larger than 35 nm, for instance no larger than about 20 nm, most advantageously no larger than about 15 nm.
Dependencies are inferred from the claim text.