References
Asahi KASEI (2018) TAE33015, Planova Virus removal Filters Product Specification Sheet
Asahi KASEI (2018) TAE34036, Validation Report Planova BioEX Filters
Barone, P. W., Wiebe, M. E., Leung, J. C., Hussein, I. T. M., Keumurian, F. J., Bouressa, J., Brussel, A., Chen, D., Chong, M., Dehghani, H., Gerentes, L., Gilbert, J., Gold, D., Kiss, R., Kreil, T. R., Labatut, R., Li, Y., Müllberg, J., Mallet, L., Menzel, C., … Springs, S. L. (2020). Viral contamination in biologic manufacture and implications for emerging therapies. Nature biotechnology, 38(5), 563–572. https://doi.org/10.1038/s41587-020-0507-2
Berting, A., Farcet, M. R., & Kreil, T. R. (2010). Virus susceptibility of Chinese hamster ovary (CHO) cells and detection of viral contaminations by adventitious agent testing. Biotechnology and bioengineering, 106(4), 598–607. https://doi.org/10.1002/bit.22723
Bethencourt, V. (2009). Virus stalls Genzyme plant. Nat Biotechnol 27, 681 (2009). https://doi.org/10.1038/nbt0809-681a
Cao, X., Stimpfl, G., Wen, Z. Q., Frank, G., & Hunter, G. (2013). Identification and root cause analysis of cell culture media precipitates in the viral deactivation treatment with high-temperature/short-time method. PDA journal of pharmaceutical science and technology, 67(1), 63–73. https://doi.org/10.5731/pdajpst.2013.00894
EMEA/CHMP/BWP/706271/2010: Guideline on plasma derived medicinal products
EMEA/CPMP/BWP/268/95 (revised in 1996). The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit: CPMP Biotechnology Working Party - Note for Guidance on Virus Validation Studies: The Design, Contribution, and Interpretation of Studies Validating the Inactivation and Removal of Viruses.
Garnick R. L. (1998). Raw materials as a source of contamination in large-scale cell culture. Developments in biological standardization, 93, 21–29.
Gombold, J., Karakasidis, S., Niksa, P., Podczasy, J., Neumann, K., Richardson, J., Sane, N., Johnson-Leva, R., Randolph, V., Sadoff, J., Minor, P., Schmidt, A., Duncan, P., & Sheets, R. L. (2014). Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products. Vaccine, 32(24), 2916–2926. https://doi.org/10.1016/j.vaccine.2014.02.021
Grillberger, L., Kreil, T. R., Nasr, S., & Reiter, M. (2009). Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnology journal, 4(2), 186–201. https://doi.org/10.1002/biot.200800241
ICH-Q5A(R1) 1999. Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Kreil TR. (2018). Building blocks of the viral safety margins of industrial plasma products. Ann Blood 2018;3:14. https://doi.org/10.21037/aob.2018.02.01
Merck Millipore (2012) DS1077EN00, Data Sheet Viresolve NFP Filter
Merck Millipore (2021) DS1401EN00, Data Sheet Viresolve Barrier Filters
Meunier, S. M., Todorovic, B., Dare, E. V., Begum, A., Guillemette, S., Wenger, A., Saxena, P., Campbell, J. L., Sasges, M., & Aucoin, M. G. (2016). Impact of Dissolved Oxygen during UV-Irradiation on the Chemical Composition and Function of CHO Cell Culture Media. PloS one, 11(3), e0150957. https://doi.org/10.1371/journal.pone.0150957.
Miesegaes, G., Lute, S., & Brorson, K. (2010). Analysis of viral clearance unit operations for monoclonal antibodies. Biotechnology and bioengineering, 106(2), 238–246. https://doi.org/10.1002/bit.22662
Moody, M., Alves, W., Varghese, J., & Khan, F. (2011). Mouse Minute Virus (MMV) Contamination–A Case Study: Detection, Root Cause Determination, and Corrective Actions. PDA journal of pharmaceutical science and technology, 65(6), 580–588. https://doi.org/10.5731/pdajpst.2011.00824.
Nims R. W. (2006). Detection of adventitious viruses in biologicals–a rare occurrence. Developments in biologicals, 123, 153–197.
Pall Life Sciences (2010) GN08.2593 USD2485, Pall Minidisc Virus removal Filter Capsules
Pall Life Sciences (2012) GN10.4151 USD2770, Pall Minidisc Capsules with Pegasus SV4 Virus Removal Filter Membrane
Pall Life Sciences (2016) GN16.6503 USD3141, Pall Microdisc Capsules with Pegasus Prime Virus Removal Filter Membrane
Parker, E. T., & Lollar, P. (2021). Conformation of the von Willebrand factor/factor VIII complex in quasi-static flow. The Journal of biological chemistry, 296, 100420. https://doi.org/10.1016/j.jbc.2021.100420
PDA (2022). Virus filtration. Technical report No. 41. PDA J Pharm Sci Technol
Sartorius Stedim Biotech GmbH (2011) SPK2065-e11029, Virosart CPV MaxiCaps and Cartridges
Sartorius Stedim Biotech GmbH (2014) SPK2143-e141201, Virosart HF Lab Modules
US Code of Federal Regulations, 21 CFR 58, Good Laboratory Practice for Nonclinical Laboratory Studies
Wieser, A., Berting, A., Medek, C., Poelsler, G., & Kreil, T. R. (2015). The evolution of down-scale virus filtration equipment for virus clearance studies. Biotechnology and bioengineering, 112(3), 633–637. https://doi.org/10.1002/bit.25452
Wieser, A., Berting, A., Medek, C., Poelsler, G., Kreil, T. R. (2016). Virus Filtration and Flow Variation: An Approach to Evaluate Any Potential Impact on Virus Retention. PDA journal of pharmaceutical science and technology, 70(4), 325–331. https://doi.org/10.5731/pdajpst.2015.006346