Evaluation and Validation of Virus Removal by Ultrafiltration During the Production of Diaspirin Crosslinked Haemoglobin (DCLHb)
| Autor: | Janelle Herren, Jennifer Paine, A. Ebeling, Theresa Camacho, Sarosh Guzder, Kimberly Rohn, James Catarello, Liang Zhang, Kristen Ogle, M. Azari, Kenneth E. Burhop, Jeri Ann Boose, Chong-Son Sun, Luisa Pearson, Alan Darling, Ramin Sarajari, Timothy N. Estep |
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| Rok vydání: | 2000 |
| Předmět: |
Viral Plaque Assay
Porcine parvovirus Erythrocytes Swine viruses Ultrafiltration Bioengineering Hemolysis Applied Microbiology and Biotechnology Virus Cell Line Microbiology law.invention Parvovirus Hemoglobins law medicine Animals Humans Hepatovirus Encephalomyocarditis virus Particle Size Filtration Pharmacology Diarrhea Viruses Bovine Viral Chromatography Aspirin General Immunology and Microbiology biology HIV Membranes Artificial Equipment Design General Medicine biology.organism_classification medicine.disease Herpesvirus 1 Suid Macaca mulatta Red blood cell medicine.anatomical_structure Evaluation Studies as Topic Viruses Safety Drug Contamination Bacteriophage phi X 174 Biotechnology |
| Zdroj: | Biologicals. 28:81-94 |
| ISSN: | 1045-1056 |
| DOI: | 10.1006/biol.2000.0246 |
| Popis: | Virus retention during ultrafiltration through A/G Technology filter cartridges was investigated to characterize the removal process and validate the degree of virus titre reduction during the filtration of red blood cell haemolysates performed as part of the production of diaspirin crosslinked haemoglobin (DCLHb). When viruses were suspended in phosphate buffered saline solution, retention was greater with larger sized viruses and smaller filter pore size. Virus titre was maintained at starting levels in the filter retentate circuit during the course of filtration, suggesting that the virus removal mechanism is predominantly size exclusion. Evaluation of specific processing variables indicated that the retention of phiX174 virus was increased in the presence of red blood cell haemolysate or at high membrane crossflow rates and transmembrane pressures, while the retention of EMC virus was less sensitive to variations in these parameters. Using these results to design a validation protocol, log reduction values of >7.9 were demonstrated for the retention of human immunodeficiency virus, pseudorabies virus and bovine viral diarrhoea viruses, 7.6 for hepatitis A virus, and 4.2 for porcine parvovirus. It was also shown that the retention of viruses was maintained during repetitive use of the same filter cartridge. |
| Databáze: | OpenAIRE |
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