[1]
|
ICH Guidelines (2011) ICH quality implementation working group points to consider (R2) I CH-Endorsed Guide for ICH Q8/Q9/Q10/Q11 Implementation. 6 December 2011.
|
[2]
|
Kumar, S., Wittmann, C. and Heinzle, E. (2004) Minibio-reactors. Biotechnology Letters, 26, 1-10.
|
[3]
|
Betts, J.I. and Baganz, F. (2006) Miniature bioreactors: Current practices and future opportunities. Microbial Cell Factories, 5, 21. doi:10.1186/1475-2859-5-21
|
[4]
|
Schapper, D., Alam, M.N., Szita, N., Eliasson Lantz, A. and Gernaey, K.V. (2009) Application of microbioreactors in fermentation process development: A review. Analytical and Bioanaytical Chemistry, 395, 679-695.
|
[5]
|
Bareither, R. and Pollard, D.A. (2010) A review of advanced small-scale parallel bioreactor technology for accelerated process development: Current state and future need. Biotechnology Progress, 27, 2-14.
|
[6]
|
Girard, P., Jordan, M., Tsao, M. and Wurm, F.M. (2001) Small-scale bioreactor system for process development and optimization. Biochemical Engineering Journal, 7, 117-119.
|
[7]
|
John, G.T., Klimant, I., Wittmann, C. and Heinzle, E. (2003) Integrated optical sensing of dissolved oxygen in microtiter plates: A novel tool for microbial cultivation. Biotechnology Bioengineering, 81, 829-836.
doi:10.1002/bit.10534
|
[8]
|
Szita, N., Boccazzi, P., Zhang, Z., Boyle, P., Sinskey, A.J. and Jensen, K.F. (2005) Development of a multiplexed microbioreactor system for high-throughput bioprocessing. Lab Chip, 5, 819-826. doi:10.1039/b504243g
|
[9]
|
Amanullah, A., Otero, J.M., Mikola, M., Hsu, A., Zhang, J., Aunins, J., Schreyer, B.H., Hope, J.A. and Russo, P.A. (2010) Novel micro-bioreactor high throughput technology for cell culture process development: Reproducibility and scalability assessment of fed-batch CHO cultures. Biotechnology Bioengineering, 106, 57-67.
|
[10]
|
Micheletti, M. and Lye, G.J. (2006) Microscale bioprocess optimisation. Current Opinion in Biotechnology, 17, 611-618.
|
[11]
|
Mazzei, D., Guzzardi, M.A., Giusti, S. and Ahluwalia, A. (2010) A low shear stress modular bioreactor for connected cell culture under high flow rates. Biotechnology Bioengineering, 106, 127-137.
|
[12]
|
Wen, Y., Zang, R., Zhang, X. and Yang, S.T. (2012) A 24-microwell plate with improved mixing and scalable performance for high throughput cell cultures. Process Biochemistry, 47, 612-618.
doi:10.1016/j.procbio.2011.12.023
|
[13]
|
Harms, P., Kostov, Y., French, J.A., Soliman, M., Anjanappa, M., Ram, A. and Rao, G. (2006) Design and performance of a 24-station high throughput microbioreactor. Biotechnology Bioengineering, 93, 6-13.
doi:10.1002/bit.20742
|
[14]
|
Isett, K., George, H., Herber, W. and Amanullah, A. (2007) Twenty-four-well plate miniature bioreactor high-through-put system: Assessment for microbial cultivations. Biotechnology Bioengineering, 98, 1017-1028.
|
[15]
|
Chen, A., Chitta, R., Chang, D. and Amanullah, A. (2009) Twenty-four well plate miniature bioreactor system as a scale-down model for cell culture process development. Biotechnology Bioengineering, 102, 148-160.
|
[16]
|
Lewis, G., Lugg, R., Lee, K. and Wales, R. (2010) Novel automated microscale bioreactor technology: A qualitative and quantitative mimic for early process development. Bioprocessing Journal, 9, 22-25.
|
[17]
|
Hsu, W.T., Aulakh, R.P., Traul, D.L. and Yuk, I.H. (2012) Advanced microscale bioreactor system: A representative scale-down model for bench-top bioreactors. Cytotechnology, 64, 667-678. doi:10.1007/s10616-012-9446-1
|
[18]
|
Manahan, M.S. and Ling, W.L. (2009) Profiling intracellular monoclonal antibody expression for improved cell culture characterization and process optimization. Bioprocessing Journal, 8, 22-27.
|