Comparison of PAT based approaches for making real-time pooling decisions for process chromatography - use of feed forward control

Journal of Chemical Technology and Biotechnology

Volumn 90, Issue 2, 2015, Pages 341-348

  Mendhe, Rakesh ^a   Thukkaram, Muralikrishnan ^b   Patil, Nitin ^b   Rathore, Anurag S ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

^b Biocon Limited   (India)

Author keywords

Feed forward control; HPLC; Preparative chromatography; Process analytical technology; Quality by design; Relative retention time

Indexed keywords

CHROMATOGRAPHY; COLUMN CHROMATOGRAPHY; COMPLIANCE CONTROL; DECISION MAKING; QUALITY ASSURANCE; QUALITY CONTROL;

HPLC; PREPARATIVE CHROMATOGRAPHY; PROCESS ANALYTICAL TECHNOLOGY; QUALITY BY DESIGNS; RELATIVE RETENTION TIME;

PROCESS CONTROL;

ARTICLE; COLUMN CHROMATOGRAPHY; DECISION MAKING; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INTERMETHOD COMPARISON; PROCESS ANALYTICAL TECHNOLOGY; PROCESS CONTROL; PROCESS MODEL; PROCESS TECHNOLOGY; ULTRAVIOLET RADIATION;

EID: 84940277459     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.4448     Document Type: Article

References (37)

1. PAT Guidance for Industry-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, US Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), September 2004.
2. Read EK, Park JT, Shah RB, Riley BS, Brorson KA and Rathore AS, Process analytical technology (PAT) for biopharmaceutical products: concepts and applications - Part I. Biotechnol Bioeng 105:276-284 (2009).
3. Read EK, Park JT, Shah RB, Riley BS, Brorson KA and Rathore AS, Process analytical technology (PAT) for biopharmaceutical products: concepts and applications - Part II. Biotechnol Bioeng 105:285-295 (2009).
4. Rathore AS, Bhambure R and Ghare V, Process analytical technology (PAT) for biopharmaceutical products. Anal Bioanal Chem 398:137-154 (2010).
5. Huber M et al., Oxidation of pharmaceuticals during ozonation and advanced oxidation processes. Environ Sci Technol 37:1016-1024 (2003).
6. Scott B and Wilcock A, PAT in the pharmaceutical industry: a toolkit for continuous improvement. PDA J Pharm Sci Technol 60:17-53 (2006).
7. Watts C and Clark J, PAT: driving the future of pharmaceutical quality. J Pro Anal Technol 6:6-9 (2006).
8. ICH, Q10 Pharmaceutical Quality System, 2008.
9. Rathore AS and Winkle H, Quality by design for pharmaceuticals: regulatory perspective and approach. Nature Biotechnol 27:26-34 (2009).
10. Rathore AS and Mhatre R (eds), Quality by Design for Biopharmaceuticals: Perspectives and Case Studies. Wiley Interscience, New Jersey, 1-8 (2009).
11. Rathore AS, Parr L, Dermawan S, Lawson K and Lu Y, Large scale demonstration of process analytical technology (PAT) in bioprocessing: use of high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol Prog 26:448-457 (2010).
12. Read EK, PAT applied in biopharmaceutical process development and manufacturing - an enabling tool for quality-by-design. Biotechnol Bioprocess Series 33:6-7 (2012).
13. Rathore AS, Bhambure R and Ghare V, Process analytical technology (PAT) for biopharmaceutical products. Anal Bioanal Chem 398:137-154 (2010).
14. Lawrence X, Robert A, Lionberger, Andre S, Rosario D'Costa, Huiquan Wu and Ajaz S, Applications of process analytical technology to crystallization processes. Adv Drug Delivery Rev 56:349-369 (2004).
15. Jestel NL, Raman spectroscopy, in Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, ed by Bakeev KA. Blackwell Publishing, Oxford, 133-169 (2005).
16. Rathore AS, Sharma A and Chilin D, Applying process analytical technology to biotech unit operations. Biopharm Int 19:48-57 (2006).
17. Rathore AS, Follow-on protein products: scientific issues, developments and challenges. Trends Biotechnol 27:698-705 (2009).
18. 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).
19. 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).
20. Rathore AS, Bhambure R and Ghare V, Process analytical technology (PAT) for biopharmaceutical products. Anal Bioanal Chem 398:137-154 (2010).
21. Yu Z, Reid JC and Yang YP, 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).
22. Oliver Kaltenbrunner, Yuefeng Lu, Ashutosh Sharma, Ken Lawson and Tim Tressel, Risk-benefit evaluation of on-line high-performance liquid chromatography analysis for pooling decisions in large-scale chromatography. J Chromatog A 1241:37-45 (2012).
23. Rathore AS and Kapoor G, Process Analytical Technology: Strategies for Biopharmaceuiticals, in Encyclopedia of Industrial Biotechnology, Wiley Interscience, New York, pp. 1543-1565 (2013).
24. Low DKR, The use of FPLC system in method development and process monitoring for industrial protein chromatography. J Chem Technol Biotechnol 36:345-350 (1986).
25. Stevenson CE and Cooley RE, On-line HPLC as a process monitor in biotechnology. Process Control Qual 2:43-53 (1992).
26. Fahrner RA, Lester PM, Blank GS and Reifsnyder DH, Real-time control of purified product collection during chromatography of recombinant human insulin-like growth factor-I using an on-line assay. J Chromatogr A 827:37-43 (1998).
27. Fahrner RA and Blank GS, Real-time control of antibody loading during protein A affinity chromatography using an on-line assay. J Chromatogr A 849:191-196 (1999).
28. Rathore AS, Saleki-Gerhardt A, Montgomery SH and Tyler SM, Quality by design for pharmaceuticals: industrial case studies on defining and implementing design space for the process. Bio Pharm Int 1:37-47 (2008).
29. Rathore AS, Saleki-Gerhardt A, Montgomery SH and Tyler SM, Quality by design for pharmaceuticals: industrial case studies on defining and implementing design space for the process. Bio Pharm Int 2:36-44 (2009).
30. Rathore AS, Parr L, Dermawan S, Lawson K and Lu Y, Large scale demonstration of process analytical technology (PAT) in bioprocessing: use of high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol Prog 26:448-457 (2010).
31. Rathore AS, Li X, Bartkowski W, Sharma A and Lu Y, Case study and application of process analytical technology (PAT) towards bioprocessing: III. Use of tryptophan fluorescence as at-line tool for making pooling decisions for process chromatography. Biotechnol Prog 25:1433-1439 (2009).
32. Rathore AS, Branning R and Cecchini D, Design space for biotech products. Bio Pharm 4:36-40 (2007).
33. Rathore AS, Wood R, Sharma A and Dermawan S, Case study and application of process analytical technology (PAT) towards bioprocessing: II. Use of ultra performance liquid chromatography (UPLC) for making real time pooling decisions for process chromatography. Biotechnol Bioeng 101:1366-1374 (2008).
34. Rathore AS, Yu M, 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).
35. Rathore AS, Kirdar AO, Conner JS and Baclaski J, Application of multivariate analysis towards biotech processes: case study of a cell-culture unit operation. Biotechnol Prog 23:61-67 (2007).
36. Westerberg K, Borg N, Andersson N and Nilsson B, Supporting design and control of a reversed-phase chromatography step by mechanistic modeling. Chem Eng Technol 35:169-175 (2012).
37. Rathore AS, Wang X, Germansderfer A and Harms J, Using statistical analysis for setting process validation acceptance criteria for biotech products. Biotechnol Prog 23:55-60 (2007).