Strategies to avoid virus transmissions by biopharmaceutic products
The use of biopharmaceutical products offers an opportunity for the treatment of many diseases. Biotechnical manufacturing using recombinant mammalian cell lines is the most appropriate method today for the production of biopharmaceutical protein drugs for the treatment of human and animal diseases. However, mammalian cell line derived products have a potential risk for virus transmission to patients who are treated with these biopharmaceutical products. The reliability that biological products are free of any viruses requires a combination of several strategies: The use of well-characterized cell bank systems and, if feasible, the avoidance of biological raw materials for the cultivation of these mammalian cell lines and the production of biopharmaceuticals. Further on, the purification process for biopharmaceuticals has to be validated for its ability to efficiently remove and inactivate any potential virus contamination and, where applicable, also unconventional transmissible agents, such as BSE. In addition, the biopharmaceutical product itself can be tested for the presence of viruses. Like other manufacturing processes, biotechnical production processes have to be performed in compliance with current Good Manufacturing Practices (cGMP).
KeywordsBovine Spongiform Encephalopathy Oxygen Uptake Rate Mammalian Cell Line Virus Contamination Model Virus
Unable to display preview. Download preview PDF.
- 1.BGA (1994) Bekanntmachung der Sicherheitsanforderungen an Arzneimittel aus Körperbestandteilen von Rind, Schaf oder Ziege zur Übertragung von BSE bzw. Scrapie. Bundesanzeiger Nr. 40, 26. Februar 1994Google Scholar
- 4.Golden RF (1994) Microwave purification for viral inactivation and bioprocess validation. Gene Eng News, May 15, 17Google Scholar
- 6.Pocchiari M (1991) Methodological aspects of the validation of purification procedures of human/animal derived products to remove unconvential slow viruses. Dev Biol Standard 75: 87–95Google Scholar
- 7.Taguehi H, Humphrey A (1966) Dynamic measurement of the volumetric oxygen transfer coefficient in fermentation systems. J Ferment Technol 44: 881–889Google Scholar
- 8.Walter JK, Werz W, Berthold W (1992) Virus removal and inactivation. Concept and data for process validation of downstream processing. Biotech Forum Europe 9: 560–564Google Scholar
- 9.Walter JK, Werz W, Berthold W (1996) Process scale considerations in evaluation studies and scale-up. In: Brown F, Lubiniecki AS (eds) Viral safety and evaluation of viral clearance from biopharmaceutical products. S. Karger, Basel, pp 99–108Google Scholar