Improved process analytical technology for protein a chromatography using predictive principal component analysis tools

Biotechnology and Bioengineering

Volumn 108, Issue 1, 2011, Pages 59-68

  Hou, Ying ^a   Jiang, Canping ^b   Shukla, Abhinav A ^b   Cramer, Steven M ^a  

^a RENSSELAER POLYTECHNIC INSTITUTE   (United States)

^b BRISTOL MYERS SQUIBB COMPANY   (United States)

Author keywords

Column integrity; Principal component analysis; Process analytical technology; Protein A chromatography; Quality by design; Yield prediction

Indexed keywords

COLUMN INTEGRITY; PRINCIPAL COMPONENTS; PROCESS ANALYTICAL TECHNOLOGY; PROTEIN A CHROMATOGRAPHY; QUALITY BY DESIGNS; YIELD PREDICTION;

ANTIBODIES; CHROMATOGRAPHIC ANALYSIS; COLUMN CHROMATOGRAPHY; DATA HANDLING; FORECASTING; RESINS; TECHNOLOGY;

PRINCIPAL COMPONENT ANALYSIS;

PROTEIN A;

ANALYTIC METHOD; ARTICLE; CHROMATOGRAPHY; CONDUCTANCE; FOOD AND DRUG ADMINISTRATION; PH; PREDICTION; PRINCIPAL COMPONENT ANALYSIS; PROCESS CONTROL; PROTEIN A CHROMATOGRAPHY; ULTRAVIOLET RADIATION;

ANTIBODIES; BIOTECHNOLOGY; CHROMATOGRAPHY, AFFINITY; PRINCIPAL COMPONENT ANALYSIS; PROTEIN BINDING; RECOMBINANT PROTEINS; STAPHYLOCOCCAL PROTEIN A;

EID: 78649410389     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22886     Document Type: Article

References (20)

1. Andersson R, Hamalainen MD. 1994. Simplex focusing of retention times and latent variable projections of chromatographic profiles. Chemometr Intell Lab Syst 22(1): 49-61.
2. Bro R, Andersson CA, Kiers HAL. 1999. PARAFAC2-Part II. Modeling chromatographic data with retention time shifts. J Chemometr 13(3-4): 295-309.
3. Bylund D, Danielsson R, Malmquist G, Markides KE. 2002. Chromatographic alignment by warping and dynamic programming as a pre-processing tool for PARAFAC modelling of liquid chromatography-mass spectrometry data. J Chromatogr A 961(2): 237-244.
4. Edwards-Parton S, Thornhill NF, Bracewell DG, Liddell JM, Titchener-Hooker NJ. 2008. Principal component score modeling for the rapid description of chromatographic separations. Biotechnol Prog 24(1): 202-208.
5. FDA. 2004. PAT-A framework for innovative pharmaceutical process development, manufacturing and quality assurance. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research.
6. Jiang C, Liu J, Rubacha M, Shukla A. 2009. A mechanistic study of protein A chromatography resin lifetime. J Chromatogr A 1216: 5849-5855.
7. Jolliffe IT. 1986. Principal component analysis. New York: Springer-Verlag. xiii, 271 p.
8. Larson TM, Davis J, Lam H, Cacia J. 2003. Use of process data to assess chromatographic performance in production-scale protein purification columns. Biotechnol Prog 19(2): 485-492.
9. Li BY, Hu Y, Liang YZ, Xie PS, Du YP. 2004. Quality evaluation of fingerprints of herbal medicine with chromatographic data. Anal Chim Acta 514(1): 69-77.
10. Malmquist G, Danielsson R. 1994. Alignment of chromatographic profiles for principal component analysis-A prerequisite for fingerprinting methods. J Chromatogr A 687(1): 71-88.
11. Neter J, Wasserman W, Kutner MH. 1989. Applied linear regression models. Burr Ridge, IL: Irwin. xv, 667 p.
12. Nielsen NPV, Carstensen JM, Smedsgaard J. 1998. Aligning of single and multiple wavelength chromatographic profiles for chemometric data analysis using correlation optimised warping. J Chromatogr A 805(1-2): 17-35.
13. Pate ME, Turner MK, Thornhill NF, Titchener-Hooker NJ. 1999. The use of principal component analysis for the modelling of high performance liquid chromatography. Bioprocess Eng 21(3): 261-272.
14. Pate ME, Turner MK, Thornhill NF, Titchener-Hooker NJ. 2004. Principal component analysis of nonlinear chromatography. Biotechnol Prog 20(1): 215-222.
15. Read EK, Park JT, Shah RB, Riley BS, Brorson KA, Rathore AS. 2010. Process analytical technology (PAT) for biopharmaceutical products: Part I. Concepts and applications. Biotechnol Bioeng 105(2): 276-284.
16. Shukla AA, Thommes J. 2010. Recent advances in large-scale production of monoclonal antibodies and related proteins. Trends Biotechnol 28(5): 253-261.
17. Shukla AA, Hubbard B, Tressel T, Guhan S, Low D. 2007. Downstream processing of monoclonal antibodies-Application of platform approaches. J Chromatogr B Analyt Technol Biomed Life Sci 848(1): 28-39.
18. Statheropoulos M, Smaragdis E, Tzamtzis N, Georgakopoulos C. 1996. Principal component analysis for resolving coeluting substances in gas chromatography-mass spectrometry doping control analysis. Anal Chim Acta 331(1-2): 53-61.
19. Torgrip RJO, Aberg M, Karlberg B, Jacobsson SP. 2003. Peak alignment using reduced set mapping. J Chemometr 17(11): 573-582.
20. Watson NE, VanWingerden MM, Pierce KM, Wright BW, Synovec RE. 2006. Classification of high-speed gas chromatography-mass spectrometry data by principal component analysis coupled with piecewise alignment and feature selection. J Chromatogr A 1129(1): 111-118.