Virus removal from factor IX by filtration: Validation of the integrity test and effect of manufacturing process conditions

Author:

Roberts Peter L.,Feldman Peter,Crombie Debbie,Walker Chris,Lowery Karen

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference16 articles.

1. Nanofiltration, a new specific virus elimination method applied to high-purity factor IX and factor XI concentrates;Burnouf-Radosevich;Vox Sang,1994

2. Removal of viruses through novel membrane filtration method;Manabe;Dev Biol Stand,1996

3. Application of virus filters to biological products: practical and regulatory considerations;Roberts;Eur J Parenter Sci,2000

4. An overview of viral filtration in biopharmaceutical manufacturing;Carter;Eur J Parenter Sci,2002

5. Nanofiltration of plasma-derived biopharmaceutical products;Burnouf;Haemophilia,2003

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