Abstract
The removability and/or permeability of DNA by the BMM virus removal filter was investigated as a function of the dispersion state of DNA in a bio-drug solution. Isolated DNA of various molecular weights and packaged DNA in a virus were filtered by BMM. Dead-end filtration was performed under a constant transmembrane pressure (TMP) of 200 mm Hg. After filtration, the DNAs captured by BMM were observed by transmission electron microscopy (TEM). In the case of BMM with a mean pore size of 15nm (BMM15), the permeability of the isolated DNA was more than 0.90 when the molecular weight was less than 107. Packaged DNAs in the virion were removed at over 5 of the logarithmic rejection coefficient. Electron microscopic observation showed that DNAs were elongated by the flow of the solution through BMM. It was concluded that the removal and reduction of contaminating DNA in bio-drugs needs to allow for the dispersion state of DNA in the solution.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Commission of the European Community (1991) ‘Validation of virus removal and inactivation procedure’.
Office of Biological Research and Review, FDA (1987) ‘Point to consider in manufacture and testing of monoclonal antibody products for human use’.
Office of Biological Research and Review, FDA (1985) ‘Point to consider in the production and testing of new drugs and biologicals produced by recombinant DNA technology’.
T. Hirasaki, T. Tsuboi, T. Noda, S. Uematsu, G. Ishikawa, A. Kono, and N. Yamamoto (1992) ‘Removability of virus particles and permeability of protein from cell culture medium using cuprammonium regenerated cellulose hollow fiber (BMMT M)’, Animal Cell Technology: Basic & Applied Aspects, Kluwer Academic Publishers, Netherlands, 49–55.
G.Ishikawa, T.Hirasaki, S.Manabe, S.Uematsu, and N.Yamamoto (1991) ‘Novel determination method of size of virus in solution using cuprammonium regenerated cellulose membrane (BMM)’, Membrane 16 (6), 376–386.
T.Yuasa, G.Ishikawa, S.Manabe, S.Sekiguchi, K. Takeuchi, and T.Miyamura (1991) ‘The particle size of hepatitis C virus estimated by filtration through microporous regenerated cellulose fiber’, J. General Virology 72, 2021–2024.
K.Sekiguchi, M.Ito, H.Kobayashi, T.Ikeda, T.Tsurumi, G.Ishikawa, S.Manabe, and T.Yamashiki (1989) ‘Possibility of hepatitis B virus (HBV) removal from human plasma using regenerated cellulose hollow fiber (BMM)’, Membrane 14 (4), 253–261.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1993 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Hirasaki, T. et al. (1993). Removability and Permeability of DNA in a Solution by Cuprammonium Regenerated Cellulose Hollow Fiber (BMMTM) for Process Validation of Purification Process of Bio-Drugs. In: Kaminogawa, S., Ametani, A., Hachimura, S. (eds) Animal Cell Technology: Basic & Applied Aspects. Animal Cell Technology: Basic & Applied Aspects, vol 5. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-2044-9_38
Download citation
DOI: https://doi.org/10.1007/978-94-011-2044-9_38
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-010-4905-4
Online ISBN: 978-94-011-2044-9
eBook Packages: Springer Book Archive