SPTFF概念及應(yīng)用原理

SPTFF應(yīng)用優(yōu)勢

通過工藝集成/耦合以及連續(xù)的上游和下游加工，提供靈活的制造工藝，適合連續(xù)生產(chǎn)工藝；

減少處理量、系統(tǒng)尺寸和設(shè)備占地面積，并帶來新穎的設(shè)備匹配解決方案，克服生產(chǎn)瓶頸；

實(shí)現(xiàn)一次性和/或一次性使用技術(shù)的利用，從而提高生產(chǎn)率，消除無附加值的加工步驟，改進(jìn)工作流程；

通過使用更小、更緊湊的系統(tǒng)，實(shí)現(xiàn)高產(chǎn)品回收率并提高產(chǎn)量；

實(shí)現(xiàn)高濃度因子，加工對剪切力高度敏感的產(chǎn)品；

大大節(jié)省資本支出、材料、勞動力和設(shè)備運(yùn)營成本。

SPTFF應(yīng)用分享

PEDV病毒疫苗測試

 a 

 b 

 c 

重組融合蛋白疫苗

 a 

 b 

 c 

mRNA-LNP緩沖液置換

 a 

 b 

 c 

血液制品-高濃靜丙 (>20%)

[1] Gaston de los Reyes and Leon Mir. Method and apparatus for the filtration of biological solutions, US Patent 7,384,549 B2 (June 10, 2008).

[2] Leon Mir and Gaston de los Reyes. Tangential flow filtration system, US Patent 7,510,654 (March 31, 2009).

[3] Gaston de los Reyes and Leon Mir. Method and apparatus for the filtration of biological solutions, US Patent 7,682,511 B2 (March 23, 2010).

[4] Gaston de los Reyes and Leon Mir. Method and apparatus for the filtration of biological solutions, US Patent 7,967,987 B2 (June 28, 2011).

[5] Gaston de los Reyes and Leon Mir. Method and apparatus for the filtration of biological solutions, US Patent 8,157,999 B2 (April 17, 2012).

[6] Leon Mir and Gaston de los Reyes. Tangential flow filtration system, US Patent 8,231,787 (July 31, 2012).

[7] Casey, C., Gallos, T., Alekseev, Y., Ayturk, E., and Pearl, S. Protein concentration with Single-Pass Tangential Flow Filtration, Journal Membrane Science, 384(1-2) (2011) 82-88.

[8] Pall Application Note (USD2789): Cadence? Systems Employ New Single-Pass TFF Technology to Simplify Processes and Lower Costs (2011).

[9] Dizon-Maspat, J., Bourret, J., D’Agostini, A. and Li, F. Single Pass Tangential Flow Filtration to Debottleneck Downstream Processing for Therapeutic Antibody Production. Biotechnology and Bioengineering, 109(4) (2011) 962-970.

[10] Casey, C. and Ayturk, E., Pall Application Note (USTR 2913): Volume Reduction and Process Optimization with Cadence? Single-Use Inline Concentrator (2013).

[11] Forespring, C., Ayturk, E., El-Agib, D., Casey, C., Bender, J. and Kuriyel, R. “Manufacturing Technologies and Case Studies to Increase Efficiency in Clinical or Commercial Production”, Poster Presentation at BioProcess International Conference and Exhibition, October 26-29, 2015, Boston, MA, USA.

[12] Casey, C., Rogler, K., Gjoka, X., Gantier, R. and Ayturk, E. “Continuous Downstream BioProcessing by Coupling Cadence? Single-Pass TFF with Chromatography Steps”, Poster Presentation at BioProcess International Conference and Exhibition, October 26-29, 2015, Boston, MA, USA.

[13] Schofield, M., Rogler, K., Gjoka, X., Ayturk, E., and Gantier, R. Pall Application Note (USD3002): Productivity and Economic Advantages of Coupling Single-pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing (2014).

[14] Casey, C. Rogler, K., Gjoka,X., Gantier, R. and Ayturk, E. Pall Application Note (USD3003): Cadence? Single-pass TFF Coupled with Chromatography Steps Enables Continuous Bioprocessing while Reducing Processing Times and Volumes (2015).

[15] Casey, C. and Ayturk, E. Pall Application Note (USD3004): Scalability of Cadence? Inline Concentrator Module for Bovine IgG Processing (2015).

[16] Casey, C., Haberman, P., Ayubali, M., and Ayturk, E. Pall Application Note (USD3005): Cleanability and Re-usability of Cadence? Inline Concentrator Modules (2015).

[17] Engin Ayturk and Rene Gantier, “Process Economics of Continuous mAb Processing with Single- Pass Tangential Flow Filtration”, Presented at 249th American Chemical Society National Meeting and Exposition, March 23-26, 2015, Denver, CO, USA.

[18] Zou, Y., Ngan, C., Hillier, B., Parrella, J., and Kozlov, M. New technologies for high concentration protein ultrafiltration: High Viscosity TFF Cassettes and Single-Pass TFF (2014).

[19] Millipore Application Note (AN5572EN00_EM): Single-pass tangential flow filtration (2014).

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