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US 2004/0110931 A1Published application
Prion and viral clearance process
OwnerRobert Van Holteninventor
Life of this patent
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Abstract
Methods for producing immunoglobulins and in particular anti-D immunoglobulin substantially free of prion and virus, and product resulting therefrom. Specifically provided are methods for nanofiltration of the anti-D immunoglobulin in high ionic strength buffer and with excipient such as polysorbate 80. Additional steps include diafiltration to concentrate the anti-D protein and reduce the concentration of excipient present.
Claims34
Substantially pure immunoglobulin.
A process for the manufacture of substantially pure prion-free anti-D antibody comprising the steps of:
- (a) resuspending Precipitate II from fractionated human plasma;
- (b) admixing the resuspended Precipitate II with processing aids;
- and
- (c) performing nanofiltration on the immunoglobulin, wherein said immunoglobulin in prion-free.
1 more element
A process for the manufacture of substantially pure protein comprising the steps of:
- (a) isolating a protein from plasma;
- (b) resuspending the isolated protein in buffer;
- (c) admixing the resuspended isolate with processing aids;
- and
- (c) performing nanofiltration on the isolate.
2 more elements
Dependencies are inferred from the claim text.