Continuous purification of active pharmaceutical ingredients using multistage organic solvent nanofiltration membrane cascade

Chemical Engineering Science

Volumn 116, Issue , 2014, Pages 183-194

  Peeva, Ludmila ^a   Burgal, Joao da Silva ^a   Valtcheva, Irina ^a   Livingston, Andrew G ^a  

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

Active pharmaceutical ingredients; Continuous purification; Green metrics; Membrane cascade; Organic solvent nanofiltration

Indexed keywords

CHARCOAL; NANOFILTRATION; NANOFILTRATION MEMBRANES; ORGANIC SOLVENTS;

4-DIMETHYLAMINOPYRIDINE; ACTIVE PHARMACEUTICAL INGREDIENTS; GREEN METRICS; MATHEMATICAL SIMULATIONS; MEMBRANE CASCADES; ORGANIC SOLVENT NANOFILTRATION; PHARMACEUTICAL INDUSTRY; PHARMACEUTICAL MANUFACTURING;

PURIFICATION;

EID: 84901327047     PISSN: 00092509     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ces.2014.04.022     Document Type: Article

References (40)

1. Abejón R., Garea A., Irabien A. Integrated countercurrent reverse osmosis cascades for hydrogen peroxide ultrapurification. Comput. Chem. Eng. 2012, 41:67-76.
2. Avgidou M.S., Kaldis S.P., Sakellaropoulos G.P. Membrane cascade schemes for the separation of LPG olefins and paraffins. J. Membr. Sci. 2004, 233:21-37.
3. Ayoob S., Gupta A.K., Bhakat P.B. Analysis of breakthrough developments and modeling of fixed bed adsorption system for As(V) removal from water by modified calcined bauxite (MCB). Sep. Purif. Technol. 2007, 52:430-438.
4. Caus A., Vanderhaegen S., Braeken L., Van der Bruggen B. Integrated nanofiltration cascades with low salt rejection for complete removal of pesticides in drinking water production. Desalination 2009, 241:111-117.
5. Constable D.J.C., Jimenez-Gonzalez C., Lapkin A. Process Green Chemistry Metrics, Green Chemistry Metrics: Measuring and Monitoring Sustainable Processes 2009, 228-247. John Wiley & Sons, Ltd. L. Alexei, D.J.C. Constable (Eds.).
6. Darvishmanesh S., Firoozpour L., Vanneste J., Luis P., Degreve J., Bruggen B.V.d. Performance of solvent resistant nanofiltration membranes for purification of residual solvent in the pharmaceutical industry: experiments and simulation. Green Chem. 2011, 13:3476-3483.
7. Degerman M., Jakobsson N., Nilsson B. Designing robust preparative purification processes with high performance. Chem. Eng. Technol. 2008, 31:875-882.
8. Ghosh R. Novel cascade ultrafiltration configuration for continuous, high-resolution protein-protein fractionation: a simulation study. J. Membr. Sci. 2003, 226:85-99.
9. Jimenez-Gonzalez C., Constable D.J.C., Ponder C.S. Evaluating the "Greenness" of chemical processes and products in the pharmaceutical industry-a green metrics primer. Chem. Soc. Rev. 2012, 41:1485-1498.
10. Keurentjes J.T.F., Linders L.J.M., Beverloo W.A., Van K., Riet'T. Membrane cascades for the separation of binary mixtures. Chem. Eng. Sci. 1992, 47:1561-1568.
11. Kim J.F., Freitas da Silva A.M., Valtcheva I.B., Livingston A.G. When the membrane is not enough: a simplified membrane cascade using Organic Solvent Nanofiltration (OSN). Sep. Purif. Technol. 2013, 116:277-286.
12. Kim J.F., Szekely G., Valtcheva I.B., Livingston A.G. Increasing the sustainability of membrane processes through cascade approach and solvent recovery-pharmaceutical purification case study. Green Chem 2014, 16:133-145.
13. Lightfoot E.N. Can membrane cascades replace chromatography? adapting binary ideal cascade theory of systems of two solutes in a single solvent. Sep. Sci. Technol. 2005, 40:739-756.
14. Lightfoot E.N., Root T.W., O'Dell J.L. Emergence of Ideal membrane cascades for downstream processing. Biotechnol. Prog. 2008, 24:599-605.
15. Lin J.C.-T., Livingston A.G. Nanofiltration membrane cascade for continuous solvent exchange. Chem. Eng. Sci. 2007, 62:2728-2736.
16. Maskan F., Wiley D.E., Johnston L.P.M., Clements D.J. Optimal design of reverse osmosis module networks. AIChE J. 2000, 46:946-954.
17. Mayani M., Filipe C.D.M., Ghosh R. Cascade ultrafiltration systems-integrated processes for purification and concentration of lysozyme. J. Membr. Sci. 2010, 347:150-158.
18. Mayani M., Mohanty K., Filipe C., Ghosh R. Continuous fractionation of plasma proteins HSA and HIgG using cascade ultrafiltration systems. Sep. Purif. Technol. 2009, 70:231-241.
19. McCandless F.P. Comparison of countercurrent recycle cascades with continuous membrane columns for gas separations. Ind. Eng. Chem. Res. 1990, 29:2167-2170.
20. Mellal M., Hui Ding L., Jaffrin M.Y., Delattre C., Michaud P., Courtois J. Separation and fractionation of oligouronides by shear-enhanced filtration. Sep. Sci. Technol. 2007, 42:349-361.
21. Mohanty K., Ghosh R. Novel tangential-flow countercurrent cascade ultrafiltration configuration for continuous purification of humanized monoclonal antibody. J. Membr. Sci. 2008, 307:117-125.
22. Mounir M., Ding L.H., Jaffrin M., Delattre C., Michaud P., Courtois J. Extraction of oligoglucuronans of low degrees of polymerisation from a fermentation broth by cascade filtration using a rotating disk module. Desalination 2006, 199:207-209.
23. Noda I., Gryte C.C. Multistage membrane separation processes for the continuous fractionation of solutes having similar permeabilities. AIChE J. 1981, 27:904-912.
24. Ormerod D., Sledsens B., Vercammen G., Van Gool D., Linsen T., Buekenhoudt A., Bongers B. Demonstration of purification of a pharmaceutical intermediate via organic solvent nanofiltration in the presence of acid. Sep. Purif. Technol. 2013, 115:158-162.
25. Overdevest P.E.M., Hoenders M.H.J., van't Riet K., van der Padt A., Keurentjes J.T.F. Enantiomer separation in a cascaded micellar-enhanced ultrafiltration system. AIChE J. 2002, 48:1917-1926.
26. Peeva L.G., Gibbins E., Luthra S.S., White L.S., Stateva R.P., Livingston A.G. Effect of concentration polarisation and osmotic pressure on flux in organic solvent nanofiltration. J. Membr. Sci. 2004, 236:121-136.
27. Rundquist E., Pink C., Vilminot E., Livingston A. Facilitating the use of counter-current chromatography in pharmaceutical purification through use of organic solvent nanofiltration. J. Chromatogr. A 2012, 1229:156-163.
28. Schmidt B., Patel J., Ricard F.X., Brechtelsbauer C.M., Lewis N. Application of process modelling tools in the scale-up of pharmaceutical crystallisation processes. Org. Process Res. Dev. 2004, 8:998-1008.
29. Sereewatthanawut I., Lim F.W., Bhole Y.S., Ormerod D., Horvath A., Boam A.T., Livingston A.G. Demonstration of molecular purification in polar aprotic solvents by organic solvent nanofiltration. Org. Process Res. Dev. 2010, 14:600-611.
30. Sheldon R. Green Chemistry in the Pharmaceutical Industry 2010, 1-20. JWiley-VCH Verlag GmbH & Co. KGaA. D. Peter J., W. Andrew S, W. Michael T. (Eds.).
31. Siew W.E., Livingston A.G., Ates C., Merschaert A. Continuous solute fractionation with membrane cascades - a high productivity alternative to diafiltration. Sep. Purif. Technol. 2013, 102:1-14.
32. Siew W.E., Livingston A.G., Ates C., Merschaert A. Molecular separation with an organic solvent nanofiltration cascade - augmenting membrane selectivity with process engineering. Chem. Eng. Sci. 2013, 90:299-310.
33. Székely G., Bandarra J., Heggie W., Sellergren B., Ferreira F.C. Organic solvent nanofiltration: a platform for removal of genotoxins from active pharmaceutical ingredients. J. Membr. Sci. 2011, 381:21-33.
34. Szekely G., Gil M., Sellergren B., Heggie W., Ferreira F.C. Environmental and economic analysis for selection and engineering sustainable API degenotoxification processes. Green Chem. 2013, 15:210-225.
35. Valtcheva I.B., Kumbharkar S.C., Kim J.F., Bhole Y., Livingston A.G. Beyond polyimide: crosslinked polybenzimidazole membranes for organic solvent nanofiltration (OSN) in harsh environments. J. Membr. Sci. 2014, 457:62-72.
36. Vandezande P., Gevers L.E.M., Vankelecom I.F.J. Solvent resistant nanofiltration: separating on a molecular level. Chem. Soc. Rev. 2008, 37:365-405.
37. Vanneste J., De Ron S., Vandecruys S., Soare S.A., Darvishmanesh S., Van der Bruggen B. Techno-economic evaluation of membrane cascades relative to simulated moving bed chromatography for the purification of mono- and oligosaccharides. Sep. Purif. Technol. 2011, 80:600-609.
38. Vanneste J., Sotto A., Courtin C.M., Van Craeyveld V., Bernaerts K., Van Impe J., Vandeur J., Taes S., Van der Bruggen B. Application of tailor-made membranes in a multi-stage process for the purification of sweeteners from Stevia rebaudiana. J. Food Eng. 2011, 103:285-293.
39. Vorotyntsev V.M., Drozdov P.N., Kolotilov E.Y. Efficient removal of condensable impurities from gases in cascades of the continuous membrane column type. Theor. Found. Chem. Eng. 2001, 35:260-265.
40. Wang L., Khan T., Mohanty K., Ghosh R. Cascade ultrafiltration bioreactor-separator system for continuous production of F(ab')2 fragment from immunoglobulin G. J. Membr. Sci. 2010, 351:96-103.