Quality by Design for peptide nanofiltration: Fundamental understanding and process selection

Chemical Engineering Science

Volumn 101, Issue , 2013, Pages 200-212

  Marchetti, Patrizia ^a,b   Butté, Alessandro ^a   Livingston, Andrew G ^b  

^a LONZA AG   (Switzerland)

^b IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

Design of Experiments; Downstream processing; Membranes; Nanofiltration; Quality by Design; Transport processes

Indexed keywords

CHROMATOGRAPHIC ANALYSIS; DESIGN; DESIGN OF EXPERIMENTS; MEMBRANES; NANOFILTRATION; NANOFILTRATION MEMBRANES; SOLVENTS;

CHROMATOGRAPHIC PURIFICATION; CONVENTIONAL TECHNIQUES; DOWNSTREAM-PROCESSING; MATHEMATICAL FRAMEWORKS; NUMERICAL OPTIMIZATIONS; PHARMACEUTICAL INDUSTRY; QUALITY BY DESIGNS; TRANSPORT PROCESS;

PEPTIDES;

EID: 84880439580     PISSN: 00092509     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ces.2013.06.014     Document Type: Article

References (18)

1. Ahmad A.L., Leo C.P., Shukor S.R.A. Statistical design of experiments for dye-salt-water separation study using bimodal porous silica/gamma-alumina membrane. Desalination Water Treat. 2009, 5:80-90.
2. Atkinson A.C., Tobias R.D. Optimal experimental design in chromatography. J. Chromatogr. A 2008, 1177:1-11.
3. Gekko K., Ohmae E., Kameyama K., Takagi T. Acetonitrile-protein interactions. amino acid solubility and preferential solvation. Biochim. Biophys. Acta 1998, 1387:195-205.
4. Hibbert D.B. Experimental design in chromatography. a tutorial review. J. Chromatogr. B 2012, 910:2-13.
5. Hosoya O., Chono S., Saso Y., Juni K., Morimoto K., Seki T. Determination of diffusion coefficients of peptides and prediction of permeability through a porous membrane. J. Pharm. Pharmacol. 2004, 56:1501-1507.
6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, August 2009. ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8(R2). 〈〉. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.
7. LoBrutto R., Jones A., Kazakevich Y.V. Effect of counter-anion concentration on retention in high-performance liquid chromatography of protonated basic analytes. J. Chromatogr. A 2001, 913:189-196.
8. Marchetti, P., Butté, A., Livingston, A., 2013. Reactive peptide nanofiltration. In: Shamim, N., Virender, S. (Eds.), Sustainable Nanotechnology and the Environment: Advances and Achievements. ACS Symposium Series.
9. Myers R.H., Montgomery D.C., Anderson-Cook C.M. Response Surface Methodology. Process and Product Optimization Using Designed Experiments 2008, Wiley Series in Probability and Statistics. third edition.
10. 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.
11. Perry R.H., Green D.W. Perry's Chemical Engineers' Handbook 1999, McGraw-Hill.
12. Polom E., Szaniawska D. Rejection of lactic acid solutions by dynamically formed nanofiltration membranes using a statistical design method. Desalination 2006, 198:208-214.
13. Román A., Vatai G., Ittzés A., Kovács Z., Czermak P. Modeling of diafiltration processes for demineralization of acid whey. an empirical approach. J. Food Process Eng. 2012, 35:708-714.
14. Shivhare M., McCreath G. Practical considerations for DoE implementation in Quality by Design. BioProcess Int. 2010, 8(6):22-30.
15. Tsuru T., Miyawaki M., Kondo H., Yoshioka T., Asaeda M. Inorganic porous membranes for nanofiltration of nonaqueous solutions. Sep. Purif. Technol. 2003, 32:105.
16. Vandezande P., Gevers L.E.M., Vankelecom I.F.J. Solvent resistant nanofiltration. separating on a molecular level. Chem. Rev. Soc. 2008, 37:365-405.
17. Yang X.J., Livingston A.G., Freitas dos Santos L. Experimental observations of nanofiltration with organic solvents. J. Membr. Sci. 2001, 190:45-55.
18. Yu L.X. Pharmaceutical quality by design. product and process development, understanding and control. Pharm. Res. 2007, 25:781-791.