Application of process analytical technology for downstream purification of biotherapeutics

Journal of Chemical Technology and Biotechnology

Volumn 90, Issue 2, 2015, Pages 228-236

  Rathore, Anurag S ^a   Kapoor, Gautam ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

Downstream processing; Filtration; Preparative chromatography; Process analytical technology (PAT); Refolding

Indexed keywords

BIOTECHNOLOGY; CHROMATOGRAPHY; FILTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; QUALITY CONTROL;

DOWNSTREAM PURIFICATIONS; DOWNSTREAM-PROCESSING; ENTIRE LIFE CYCLES; MANUFACTURING PROCESS; PREPARATIVE CHROMATOGRAPHY; PROCESS ANALYTICAL TECHNOLOGY; PROCESS PERFORMANCE; REFOLDING;

LIFE CYCLE;

BIOLOGICAL PRODUCT;

BIOTECHNOLOGY; CIRCULAR DICHROISM; DOWNSTREAM PROCESSING; FILTRATION; FLUORESCENCE SPECTROSCOPY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PROCESS TECHNOLOGY; PROTEIN REFOLDING; REVIEW;

EID: 84920914665     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.4447     Document Type: Review

References (39)

1. Guidance for industry PAT-a framework for innovative pharmaceutical development, manufacturing, and quality assurance. Available at http://www.fda.gov/cder/guidance/index.htm. September 2004.
2. Rathore AS, Bhambure R and Ghare V, Process analytical technology (PAT) for biopharmaceutical products.Analyt Bioanalyt Chem 398:137-154 (2010).
3. Rathore AS and Kapoor G, Process analytical technology: strategies for biopharmaceuticals. Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation and Cell Technology. 1543-1565 (2013).
4. Read EK, Park JT, Shah RB, Riley BS, Brorson KA and Rathore AS, Process analytical technology (PAT) for biopharmaceutical products: Part I. Concepts and applications. Biotechnol Bioeng 105:276-284 (2010).
5. Read EK, Shah RB, Riley BS, Park JT, Brorson KA and Rathore AS, Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications. Biotechnol Bioeng 105:285-295 (2010).
6. Freydell EJ, van der Wielen LAM, Eppink MHM and Ottens M, Techno-economic evaluation of an inclusion body solubilization and recombinant protein refolding process. Biotechnol Prog 27:1315-1328 (2011).
7. Rathore AS, Bade P, Joshi V, Pathak M and Pattanayek SK, Refolding of biotech therapeutic proteins expressed in bacteria: review. J Chem Technol Biotechnol 88:1794-1806 (2013).
8. Pizarro SA, Dinges R, Adams R, Sanchez A and Winter C, Biomanufacturing process analytical technology (PAT) application for downstream processing: using dissolved oxygen as an indicator of product quality for a protein refolding reaction. Biotechnol Bioeng 104:340-351 (2009).
9. Yu, Z, Reid, JC and Yang Y-P, Utilizing dynamic light scattering as a process analytical technology for protein folding and aggregation monitoring in vaccine manufacturing. J Pharm Sci 102:4284-4290 (2013).
10. Walther C, Mayer S, Jungbauer A and Dürauer A, >Getting ready for PAT: scale up and inline monitoring of protein refolding of Npro fusion proteins Process Biochem 49(7):1113-1121 (2014).
11. Chhatre S, Bou-Habib G, Smith MP, Hoare M, Bracewell DG and Titchener-Hooker NJ, Use of PAT principles for the open-loop control of laboratory and pilot-scale chromatography columns. J Chem Technol Biotechnol 84:1314-1322 (2009).
12. Kamga M-H, Lee WH, Liu J and Yoon S, Quantification of protein mixture in chromatographic separation using multi-wavelength UV spectra. Biotechnol Prog 29:664-671 (2013).
13. Vyas V, Nellis D and Burnette A, From Abstracts of Papers, 238th ACS National Meeting, Washington DC, United States, August 16-20, 2009, BIOT-396. Database: CAPLUS
14. Yan B, Chen T, Xu Z and Qu H, Rapid process development of chromatographic process using direct analysis in real time mass spectrometry as a process analytical technology tool. J Pharm Biomed Anal 94:106-110 (2014)
15. Mendhe, R, Muralikrishnan T, Patil N and Rathore AS, Comparison of PAT based approaches for making real-time pooling decisions for process chromatography- use of feed forward control. J Chem Technol Biotechnol DOI: 10.1002/jctb.4448 (2014).
16. Kaltenbrunner, O, Lu Y, Sharma A, Lawson K and Tressel T, Risk-benefit evaluation of on-line high-performance liquid chromatography analysis for pooling decisions in large-scale chromatography. J Chromatogr A 1241:37-45 (2012).
17. Undey C, Ertunc S, Mistretta T and Looze B, Applied advanced process analytics in biopharmaceutical manufacturing: challenges and prospects in real-time monitoring and control. Process Control 20:1009-1018 (2010).
18. Rathore AS, Marcella Yu, Yeboah S and Sharma A, Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high- performance liquid chromatography(HPLC) for making real-time pooling decisions for process chromatography. Biotechnol Bioeng 100:306-316 (2008).
19. Rathore AS, Li X, Bartkowski W, Sharma A and Lu Y, Case study and application of process analytical technology (PAT) towards bioprocessing: use of tryptophan fluorescence as At-line tool for making pooling decisions for process chromatography, Biotechnol Prog 25:1433-1439 (2009).
20. Li Y, Weiss WF and Roberts CJ, Characterization of high-molecular-weight nonnative aggregates and aggregation kinetics by size exclusion chromatography with inline multi-angle laser light scattering. J Pharm Sci 98:3997-4016 (2009).
21. Brestrich N, Briskot J, Osberghaus A and Hubbuch J, A tool for selective inline quantification of co-eluting proteins in chromatography using spectral analysis and partial least squares regression. Biotechnol Bioeng 111:1365-1373 (2014).
22. Rathore AS, Mittal S, Lute S and Brorson K, Chemometrics applications in biotech processes: predicting column Integrity and impurity clearance during reuse of chromatography resin Biotechnol Prog 28:1308-1314 (2012).
23. Bork C, Holdridge S, Walter M, Fallon E and Pohlscheidt M, Online integrity monitoring in the Protein A step of mAb production processes-increasing reliability and process robustness Biotechnol Prog 30:383-390 (2014).
24. Hou Y, Jiang C, Shukla AA and Cramer SM, Improved process analytical technology for protein a chromatography using predictive principal component analysis tools. Biotechnol Bioeng 108(1):59-68 (2011).
25. Rathore AS and Shirke A, Recent developments in membrane-based separations in biotechnology processes - review. Preparative Biochem Biotechnol 41:307-315 (2011).
26. Grote F, Fröhlich H and Strube J, Integration of ultrafiltration unit operations in biotechnology process design. Chem Eng Technol 34:673-687 (2011).
27. Rathore AS, Kumar V, Arora A, Lute S, Brorson K and Shukla A, Mechanistic modeling of viral filtration J Membrane Sci 458:96-103 (2014).
28. Fluorescence spectroscopy: a tool for protein folding/unfolding study, Available online at www.physics.nus.edu.sg/ .../Fluorescence%20Spectroscopy007.pdf
29. Kolvenbach CG, Elliott S, Sachdev R, Arakawa T and Narhi LO, Characterization of two fluorescent tryptophans in recombinant human granulocyte colony stimulating factor: comparison of native sequence protein and tryptophan deficient mutants. J Protein Chem 12:229-236 (1993).
30. Narhi LO, Kenny WC and Arakawa T, Conformational changes of recombinant human granulocyte colony stimulating factor induced by pH and guanidine hydrochloride. J Protein Chem 10:359-367 (1991).
31. Saxena AM, Krishnamoorthy G, Udgaonkar JB and Periasamy N, Identification of intermediate species in protein-folding by quantitative analysis of amplitudes in time-domain fluorescence spectroscopy. J Chem Sci 119:61-69 (2007).
32. Greenfield NJ, Using circular dichroism spectra to estimate protein secondary structure. Nat Protocol 1:2876-2890 (2006).
33. Raso SW, Abel J, Barnes JM, Malone KM, Pipes G, Treuheit MJ, King J and Brems DN, Aggregation of granulocyte-colony stimulating factor in vitro involves a conformationally altered monomeric state. Protein Sci 14:2246-2257 (2005).
34. Joshi V, Shivach T, Kumar V, Yadav N and Rathore AS, Avoiding antibody aggregation during processing: establishing hold times. Biotechnol J DOI:10.1002/biot.201400052 (2014)
35. Kane AS, Hoffmann A, Baumga P, Horsley DA, Schuler B and Bakajin O, Microfluidic mixers for the investigation of rapid protein folding kinetics using synchrotron radiation circular dichroism spectroscopy. Anal Chem 80:9534-9541(2008).
36. Konermann L, Pan J and Wilson DJ, Protein folding mechanisms studied by time-resolved electrospray mass spectrometry BioTechniques 40:135-141 (2006)
37. Schanda P, Forge V and Brutscher B, Protein folding and unfolding studied at atomic resolution by fast two-dimensional NMR spectroscopy. PNAS 104:11257-11262 (2007).
38. Stark E, Hitzmann B, Schugerl K, Scheper T, Fuchs C, Koster D and Markl H, In Situ fluorescence probes: a useful tool for non-invasive bioprocess monitoring. Adv Biochem Eng/Biotechnol 74:21-38 (2002).
39. Wang NS and Simmons MB, Characterization of an on-line commercial fluorescence probe: modeling of the probe signal. Biotechnol Bioeng 38:1292-1301 (1991).