Fully aseptic single-use cross flow filtration system for clarification and concentration of cytomegalovirus-like particles

Engineering in Life Sciences

Volumn 14, Issue 3, 2014, Pages 318-326

  Vicente, Tiago ^a   Burri, Stephanie ^a   Wellnitz, Sabine ^a   Walsh, Kieron ^b   Rothe, Sebastian ^c   Liderfelt, Jakob ^d  

^a Redbiotec AG   (Switzerland)

^b GE Healthcare Life Sciences   (United States)

^c GE HEALTHCARE   (United States)

^d BIACORE AB   (Sweden)

Author keywords

Cross flow filtration; Cytomegalovirus; Process development; Vaccine; VLP

Indexed keywords

VACCINES; VIRUSES;

CROSS FLOW FILTRATION; CROSS-FLOW FILTRATION SYSTEM; CYTOMEGALOVIRUS; MANUFACTURING PROCESS; PRECLINICAL DEVELOPMENT; PROCESS DEVELOPMENT; TRANSMEMBRANE PRESSURES; VLP;

CLARIFIERS;

ENDOTOXIN;

CONCENTRATION (COMPOSITION); FILTRATION; FLOW PATTERN; MANUFACTURING; OPERATIONS TECHNOLOGY; PROCESSING; TECHNOLOGY ADOPTION; VACCINE;

ANIMAL CELL; ARTICLE; ASEPSIS; CELL VIABILITY; COST EFFECTIVENESS ANALYSIS; CROSSFLOW FILTRATION; CYTOMEGALOVIRUS; DIAFILTRATION; HOLLOW FIBER; MICROBIAL CONTAMINATION; NONHUMAN; PROCESS DEVELOPMENT; ULTRAFILTRATION; VIRUS LIKE AGENT;

EID: 84901193526     PISSN: 16180240     EISSN: 16182863     Source Type: Journal    
DOI: 10.1002/elsc.201300093     Document Type: Article

References (36)

1. Smith, G. E., Flyer, D. C., Raghunandan, R., Liu, Y. et al., Development of influenza H7N9 virus like particle (VLP) vaccine: homologous A/Anhui/1/2013 (H7N9) protection and heterologous A/chicken/Jalisco/CPA1/2012 (H7N3) cross-protection in vaccinated mice challenged with H7N9 virus. Vaccine 2013, 31, 4305-4313.
2. Vicente, T., Peixoto, C., Carrondo, M. J., Alves, P. M., Purification of recombinant baculoviruses for gene therapy using membrane processes. Gene. Ther. 2009, 16, 766-775.
3. Vicente, T., Mota, J. P., Peixoto, C., Alves, P. M. et al., Rational design and optimization of downstream processes of virus particles for biopharmaceutical applications: current advances. Biotechnol Adv. 2011, 29, 869-878.
4. ISO, ISO 13408-1:2008: Aseptic Processing of Health Care Products. 2008.
5. FDA, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Process. 2004.
6. Rothe, S., Ries, C., Eibl, D., Walsh, K. et al., Method for preserving cell density and viability in two-phase fed-bath CHO culture. Bioproc. Int. 2012, 10, 50-61.
7. Eibl, R., Steiger, N., Wellnitz, S., Vicente, T. et al., Fast single-use VLP vaccine productions based on insect cells and the baculovirus expression vector system: influenza as case study. Adv. Biochem. Eng. Biotechnol. 2014, 138, 99-125.
8. Rodriguez-Limas, W. A., Sekar, K., Tyo, K. E., Virus-like particles: the future of microbial factories and cell-free systems as platforms for vaccine development. Curr. Opin. Biotechnol 2013, 24, 1089-1093.
9. Coleman, J. L., Shukla, D., Recent advances in vaccine development for herpes simplex virus types I and II. Hum. Vaccin. Immunother 2013, 9, 729-735.
10. Li, M., Qiu, Y. X., A review on current downstream bio-processing technology of vaccine products. Vaccine 2013, 31, 1264-1267.
11. Roldão, A., Mellado, M. C., Castilho, L. R., Carrondo, M. J. et al., Virus-like particles in vaccine development. Expert. Rev. Vaccines 2010, 9, 1149-1176.
12. Buckland, B. C., The process development challenge for a new vaccine. Nat. Med. 2005, 11; S16-S19.
13. Vicente, T., Roldao, A., Peixoto, C., Carrondo, M. J. et al., Large-scale production and purification of VLP-based vaccines. J. Invertebr. Pathol. 2011, 107(Suppl), S42-S48.
14. Lightfoot, E. N., Moscariello, J. S., Bioseparations. Biotechnol Bioeng. 2004, 87, 259-273.
15. Wolff, M. W., Reichl, U., Downstream processing of cell culture-derived virus particles. Expert Rev. Vaccines 2011, 10, 1451-1475.
16. Morenweiser, R., Downstream processing of viral vectors and vaccines. Gene. Ther. 2005, 12, S103-S110.
17. Charcosset, C., Membrane processes in biotechnology: an overview. Biotechnol Adv. 2006, 24, 482-492.
18. Konz, J. O., Pitts, L. R., Sagar, S. L., Scaleable purification of adenovirus vectors. Methods Mol. Biol. 2008, 434, 13-23.
19. Peixoto, C., Ferreira, T. B., Sousa, M. F. Q., Carrondo, M. J. T. et al., Towards purification of adenoviral vectors based on membrane technology. Biotechnol Prog. 2008, 24, 1290-1296.
20. Segura, M. M., Puig, M., Monfar, M., Chillón M., Chromatography purification of canine adenoviral vectors. Hum. Gene Ther. Methods 2012, 23, 182-187.
21. Cecchini, S., Virag, T., Kotin, R. M., Reproducible high yields of recombinant adeno-associated virus produced using invertebrate cells in 0.02- to 200-liter cultures. Hum. Gene. Ther. 2011, 22, 1021-1030.
22. Merten, O. W., Geny-Fiamma, C., Douar, A. M., Current issues in adeno-associated viral vector production. Gene. Ther. 2005, 12, S51-S61.
23. Grein, T. A., Michalsky, R., Czermak, P., Virus separation using membranes. Methods Mol. Biol. 2014, 1104, 459-491.
24. Peixoto, C., Sousa, M. F. Q., Silva, A. C., Carrondo, M. J. T., Alves, P. M., Downstream processing of triple layered rotavirus like particles. J. Biotechnol 2007, 127, 452-461.
25. Rodrigues, T., Carvalho, A., Carmo, M., Carrondo, M. et al., Scaleable purification process for gene therapy retroviral vectors. J. Gene. Med. 2007, 9, 233-243.
26. Kommareddy, S., Bonificio, A., Gallorini, S., Baudner, B. et al., Preparation of highly concentrated influenza vaccine for use in novel delivery approaches. J. Pharm. Sci. 2013, 102, 866-875.
27. Wickramasinghe, S. R., Kalbfuss, B., Zimmermann, A., Thom, V. et al., Tangential flow microfiltration and ultrafiltration for human influenza A virus concentration and purification. Biotechnol. Bioeng. 2005, 92, 199-208.
28. Negrete, A., Pai, A., Shiloach, J., Use of hollow fiber tangential flow filtration for the recovery and concentration of HIV virus-like particles produced in insect cells. J. Virol. Methods 2014, 195, 240-246.
29. Cruz, P. E., Peixoto, C. C., Devos, K., Moreira, J. L. et al., Characterization and downstream processing of HIV-1 core and virus-like-particles produced in serum free medium. Enzyme Microb. Technol. 2000, 26, 61-70.
30. Maranga, L., Rueda, P., Antonis, A. F., Vela, C. et al., Large scale production and downstream processing of a recombinant porcine parvovirus vaccine. Appl. Microbiol. Biotechnol. 2002, 59, 45-50.
31. Hensgen, M. I., Czermak, P., Carlson, J. O., Wickramasinghe, S. R., Purification of minute virus of mice using high performance tangential flow filtration. Desalination 2010, 250, 1121-1124.
32. Langfield, K. K., Walker, H. J., Gregory, L. C., Federspiel, M. J., Manufacture of measles viruses. Methods Mol. Biol. 2011, 737, 345-366.
33. Subramanian, S., Altaras, G. M., Chen, J., Hughes, B. S. et al., Pilot-scale adenovirus seed production through concurrent virus release and concentration by hollow fiber filtration. Biotechnol. Prog. 2005, 21, 851-859.
34. Palomares, L., Pedroza, R., Ramirez, O., Cell size as a tool to predict the production of recombinant protein by the insect-cell baculovirus expression system. Biotechnol Lett. 2001, 23, 359-364.
35. Zeman, L., Zydney, A., Microfiltration and Ultrafiltration. Principles and Applications. Marcel Dekker, New York 1996.
36. van Reis, R., Zydney, A., Membrane separations in biotechnology. Curr. Opin. Biotechnol. 2001, 12, 208-211.