Review: Microscale methods for high-throughput chromatography development in the pharmaceutical industry

Journal of Chemical Technology and Biotechnology

Volumn 84, Issue 7, 2009, Pages 927-940

  Chhatre, Sunil ^a   Titchener Hooker, Nigel J ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Batch incubation; Chromatography; Design of experiments; Filter plate; High throughput; Microscale; Miniature columns; Pipette tips; Quality by design

Indexed keywords

BATCH INCUBATION; FILTER PLATE; HIGH THROUGHPUT; MICROSCALE; MINIATURE COLUMNS; PIPETTE TIPS; QUALITY BY DESIGN;

CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; DESIGN OF EXPERIMENTS; DRUG PRODUCTS PLANTS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; OPERATING COSTS; RESINS;

THROUGHPUT;

BUFFER; RESIN;

ACCURACY; ADSORPTION; ANALYTIC METHOD; ANALYTICAL ERROR; ANALYTICAL PARAMETERS; BATCH PROCESS; BIOPROCESS; BIOTECHNOLOGY; CENTRIFUGATION; CHROMATOGRAPHY; CLINICAL LABORATORY; COLUMN CHROMATOGRAPHY; COMPUTER MODEL; COST BENEFIT ANALYSIS; DRUG INDUSTRY; DRUG PURIFICATION; DRUG RESEARCH; ENZYME LINKED IMMUNOSORBENT ASSAY; EVAPORATION; FILTRATION; FINANCIAL MANAGEMENT; GEL ELECTROPHORESIS; GEOMETRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; HYDROPHOBICITY; INCUBATION TIME; INTERMETHOD COMPARISON; ION EXCHANGE; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PREDICTION; PROCESS DESIGN; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUALITATIVE ANALYSIS; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; REVIEW; ROBOTICS; SEPARATION TECHNIQUE; SOCIOECONOMICS; STANDARDIZATION; SURFACE ENHANCED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY;

EID: 67650911692     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.2125     Document Type: Review

References (44)

1. Pryzbycien TM, Pujar NS and Steele LM, Alternative bioseparation operations: life beyond packed-bed chromatography. Curr Opin Biotechnol 15:469-478 (2004).
2. Boi C, Membrane adsorbers as purification tools for monoclonal antibody purification. J Chromatogr B 848:19-27 (2007).
3. Low D, O'Leary R and Pujar NS, Future of antibody purification. J Chromatogr B 848:48-63 (2007).
4. Mehta A, Tse ML, Fogle J, Len A, Shrestha R, Fontes N, et al, Purifying therapeutic monoclonal antibodies, Chem Eng Prog (Society of Biological Engineering supplement), 104:S14-S20 (2008).
5. Farid S, Novais JL, Karri S, Washbrook J and Titchener-Hooker NJ, A tool for modelling strategic decisions in cell culture manufacturing. Biotechnol Progr 16:829-836 (2000).
6. Lakhdar K, Farid SS, Titchener-Hooker NJ and Papageorgiou LG, Medium term planning of biopharmaceutical manufacture with uncertain fermentation titers. Biotechnol Progr 22:1630-1636 (2006).
7. Wenger MD, DePhillips P, Price CE and Bracewell DG, An automated microscale chromatographic purification of virus-like particles as a strategy for process development. Biotechnol Appl Biochem 47:131-139 (2007).
8. Sofer G and Hagel L, Purification design, optimisation and scale-up. in Handbook of Process Chromatography: A Guide to Optimization, Scale-up, and Validation, 3rd edn. Academic Press, London (2001).
9. Rathore AS and Velayudhan A, Scale-Up and Optimization in Preparative Chromatography: Principles and Biopharmaceutical Applications. Chromatographic Science Series, Marcel Dekker, New York, pp 12-14 (2003).
10. Aldington S and Bonnerjea J, Scale-up of monoclonal antibody purification processes. J Chromatogr B 848:64-78 (2007).
11. Wierling PS, Bogumil R, Knieps-Grünhagen E and Hubbuch J, High-throughput screening of packed-bed chromatography coupled with SELDI-TOF MS analysis: monoclonal antibodies versus host cell protein. Biotechnol Bioeng 98:440-450 (2007).
12. Dismer F, Petzold M and Hubbuch J, Effects of ionic strength and mobile phase pH on the binding orientation of lysozyme on different ion-exchange adsorbents. J Chromatogr A 1194:11-21 (2008).
13. Gavin PF and Olsen BA, A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603). J Pharmaceut Biomed 46:431-441 (2008).
14. Wechsler J, FDA encourages Quality by Design initiatives. Biopharm Int 21:14-16 (2008).
15. Houlton S, Quality by design. Chemistry and Industry 8:21-23 (2008).
16. Bergander T, Nilsson-Välimaa K, Öberg K and Łacki KM, High-throughput process development: determination of dynamic binding capacity using microtiter filter plates filled with chromatography resin. Biotechnol Progr 24:632-639 (2008).
17. Titchener-Hooker NJ, Dunnill P and Hoare M, Micro biochemical engineering to accelerate the design of industrial-scale downstream processes for biopharmaceutical proteins. Biotechnol Bioeng 100:473-487 (2008).
18. Lye GJ, Ayazi-Shamlou P, Baganz F, Dalby PA and Woodley JM, Accelerated design of bioconversion processes using automated microscale processing techniques. Trends Biotechnol 21:29-37 (2003).
19. Micheletti M and Lye G, Microscale bioprocess optimisation. Curr Opin Biotechnol 17:611-618 (2006).
20. Lamping SR, Zhang H, Allen B and Ayazi Shamlou P, Design of a prototype miniature bioreactor for high throughput automated bioprocessing. Chem Eng Sci 58:747-758 (2003).
21. Jackson NB, Liddell JM and Lye GJ, An automated microscale technique for the quantitative and parallel analysis of microfiltration operations. J Membrane Sci 276:31-41 (2006).
22. Charlton H, Galarza B, Leriche K and Jones R, Chromatography process development using 96-well microplate formats. Biopharm Int 2nd June 2006, on-line from http://biopharminternational.findpharma.com/ [accessed 20th October 2008].
23. Stein A and Kiesewetter A, Cation exchange chromatography in antibody purification: pH screening for optimised binding and HCP removal. J Chromatogr B 848:151-158 (2007).
24. Kramarczyk JF, Kelley BD and Coffman JL, High-throughput screening of chromatographic separations: II. Hydrophobic interaction. Biotechnol Bioeng 100:707-720 (2008).
25. Coffman JL, Kramarczyk JF and Kelley BD, High-throughput screening of chromatographic separations: I. Method development and column modelling. Biotechnol Bioeng 100:605-618 (2008).
26. Wensel DL, Kelley BD and Coffman JL, High-throughput screening of chromatographic separations: III. Monoclonal antibodies on ceramic hydroxyapatite. Biotechnol Bioeng 100:839-854 (2008).
27. Kelley BD, Switzer M, Bastek P, Kramarczyk JF, Molnar K, Yu T, et al, High-throughput screening of chromatographic separations: IV. Ion-exchange. Biotechnol Bioeng 100:950-963 (2008).
28. Kelley B, Tobler SA, Brown P, Coffman JL, Godavarti R, Iskra T, et al, Weak partitioning chromatography for anion exchange purification of monoclonal antibodies. Biotechnol Bioeng 101:553-566 (2008).
29. Rege K, Pepsin M, Falcon B, Steele L and Heng M, High-throughput process development for ecombinant protein purification. Biotechnol Bioeng 93:618-630 (2006).
30. Herrmann T, Schröder M and Hubbuch J, Generation of equally sized particle plaques using solid-liquid suspensions. Biotechnol Progr 22:914-918 (2006).
31. Staby A, Jensen RH, Bensch M, Hubbuch J, Dünweber DL, Krarup J, et al, Comparison of chromatographic ion-exchange resins VI. Weak anion-exchange resins. J Chromatogr A 1164:82-94 (2007).
32. Bensch M, Wierling PS, von Lieres E and Hubbuch J, High throughput screening of chromatographic phases for rapid process development. Chemical Engineering and Technology 28:1274-1284 (2005).
33. Łacki KM, Bergander T, Grönberg A and Öberg K, High throughput process development: Determination of dynamic binding capacity using microtiter plates filled with chromatography resins, oral presentation to the Downstream Processing: High Throughput Screening in Process Development session (BIOT 470), Division of Biochemical Technology, The 234th ACS National Meeting, Boston, Massachusetts, USA, 19-23 August (2007).
34. Shukla AK, Shukla MM and Shukla AM, Incision-based filtration/separation pipette tip. US Patent 7276158 (2007).
35. Williams JG and Tomer KB, Disposable chromatography for a high-throughput nano-ESI/MS and nano-ESI/MS-MS platform, J Am Soc Mass Spectr, 15:1333-1340 (2004).
36. Wenger MD, DePhillips P and Bracewell DG, A microscale yeast cell disruption technique for integrated process development strategies, Biotechnol Progr 24:606-614 (2008).
37. Britsch L, Schroeder T and Friedle J, Small-scale parallelized biochromatography. Genetic Engineering and Biotechnology News 28:(2008). on-line from www.genengnews.com [accessed 20th October 2008].
38. Britsch L, Schroeder T and Friedle J, Automated, high-throughput chromatographic separation of biological compounds. Am Biotechnol Lab 26:20-23 (2008).
39. Thiemann J, Jankowski J, Rykl J, Kurzawski S, Pohl T, Wittmann-Liebold B et al, Principle and applications of the protein-purification parameter screening system. J Chromatogr A 1043:73-80 (2004).
40. Kaltenbrunner O, Jungbauer A and Yamamoto S, Prediction of the preparative chromatography performance with a very small column. J Chromatogr A 760:41-53 (1997).
41. Allenby G, Alton G, Benn N, Fransson K and Keller TH, Driving lab automation forward. European Pharmaceutical Review 6:35-41 (2007).
42. Flatman S, Alam I, Gerard J and Mussa N, Process analytics for purification of monoclonal antibodies. J Chromatogr B 848:79-87 (2007).
43. DiBella E, Meacle F and Alred P, Case study: fitting a difficult monoclonal antibody into a platform process while maintaining timelines. 13th Recovery of Biological Products Conference, 22-27 June (2008). Québec City, Québec, Canada.
44. Gottschalk U, Bioseparation in antibody manufacturing: the good, the bad and the ugly. Biotechnol Progr 24:496-503 (2008).