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Volumn 32, Issue 6, 2014, Pages 329-336

Multivariate PAT solutions for biopharmaceutical cultivation: Current progress and limitations

Author keywords

Biopharmaceutical industry; Cell cultivation; Process analytical technology; Quality by design

Indexed keywords

INDUSTRY;

EID: 84901001859     PISSN: 01677799     EISSN: 18793096     Source Type: Journal    
DOI: 10.1016/j.tibtech.2014.03.008     Document Type: Review
Times cited : (84)

References (64)
  • 6
    • 68049113335 scopus 로고    scopus 로고
    • Quality-by-design for biotechnology-related pharmaceuticals
    • Mandenius C-F., et al. Quality-by-design for biotechnology-related pharmaceuticals. Biotechnol. J. 2009, 4:600-609.
    • (2009) Biotechnol. J. , vol.4 , pp. 600-609
    • Mandenius, C.-F.1
  • 7
    • 60149106150 scopus 로고    scopus 로고
    • Quality by design for biopharmaceuticals
    • Rathore A.S., Winkle H. Quality by design for biopharmaceuticals. Nat. Biotechnol. 2009, 27:26-34.
    • (2009) Nat. Biotechnol. , vol.27 , pp. 26-34
    • Rathore, A.S.1    Winkle, H.2
  • 8
    • 68749083515 scopus 로고    scopus 로고
    • Roadmap for implementation of quality by design (QbD) for biotechnology products
    • Rathore A.S. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009, 27:546-553.
    • (2009) Trends Biotechnol. , vol.27 , pp. 546-553
    • Rathore, A.S.1
  • 9
    • 84868109980 scopus 로고    scopus 로고
    • The business benefits of quality by design (QbD)
    • Kourti T., Davis B. The business benefits of quality by design (QbD). Pharm. Eng. 2012, 32:52-62.
    • (2012) Pharm. Eng. , vol.32 , pp. 52-62
    • Kourti, T.1    Davis, B.2
  • 10
    • 84860708861 scopus 로고    scopus 로고
    • Enhancing crystalline properties of a cardiovascular active pharmaceutical ingredient using a process analytical technology based crystallization feedback control strategy
    • Saleemi A.N., et al. Enhancing crystalline properties of a cardiovascular active pharmaceutical ingredient using a process analytical technology based crystallization feedback control strategy. Int. J. Pharm. 2012, 430:56-64.
    • (2012) Int. J. Pharm. , vol.430 , pp. 56-64
    • Saleemi, A.N.1
  • 11
    • 79955482269 scopus 로고    scopus 로고
    • Process analytical technology applied for end-point detection of pharmaceutical blending by combining two calibration-free methods: simultaneously monitoring specific near-infrared peak intensity and moving block standard deviation
    • Momose W., et al. Process analytical technology applied for end-point detection of pharmaceutical blending by combining two calibration-free methods: simultaneously monitoring specific near-infrared peak intensity and moving block standard deviation. Powder Technol. 2011, 210:122-131.
    • (2011) Powder Technol. , vol.210 , pp. 122-131
    • Momose, W.1
  • 12
    • 74149094436 scopus 로고    scopus 로고
    • On-line monitoring of residual solvent during the pharmaceutical drying process using non-contact infrared sensor: a process analytical technology (PAT) approach
    • Tewari J., et al. On-line monitoring of residual solvent during the pharmaceutical drying process using non-contact infrared sensor: a process analytical technology (PAT) approach. Sens. Actuators B. Chem. 2010, 144:104-111.
    • (2010) Sens. Actuators B. Chem. , vol.144 , pp. 104-111
    • Tewari, J.1
  • 13
    • 77955984086 scopus 로고    scopus 로고
    • Process analytical technology (PAT) for biopharmaceutical products
    • Rathore A.S., et al. Process analytical technology (PAT) for biopharmaceutical products. Anal. Bioanal. Chem. 2010, 389:137-154.
    • (2010) Anal. Bioanal. Chem. , vol.389 , pp. 137-154
    • Rathore, A.S.1
  • 14
    • 70349330797 scopus 로고    scopus 로고
    • Biomanufacturing process analytical technology (PAT) application for downstream processing: using dissolved oxygen as an indicator of product quality for a protein refolding reaction
    • Pizarro S.A., et al. 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. 2009, 104:340-351.
    • (2009) Biotechnol. Bioeng. , vol.104 , pp. 340-351
    • Pizarro, S.A.1
  • 15
    • 44449122383 scopus 로고    scopus 로고
    • 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
    • Rathore A.S., et al. 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. 2008, 100:306-316.
    • (2008) Biotechnol. Bioeng. , vol.100 , pp. 306-316
    • Rathore, A.S.1
  • 16
    • 84888085063 scopus 로고    scopus 로고
    • QbD and PAT in upstream and downstream processing
    • Haigney S. QbD and PAT in upstream and downstream processing. Biopharm. Int. 2013, 26:28-37.
    • (2013) Biopharm. Int. , vol.26 , pp. 28-37
    • Haigney, S.1
  • 17
    • 84870688374 scopus 로고    scopus 로고
    • How can measurement, monitoring, modeling and control advance cell culture in industrial biotechnology?
    • Carrondo M.J.T., et al. How can measurement, monitoring, modeling and control advance cell culture in industrial biotechnology?. Biotechnol. J. 2012, 7:1522-1529.
    • (2012) Biotechnol. J. , vol.7 , pp. 1522-1529
    • Carrondo, M.J.T.1
  • 18
    • 84877013068 scopus 로고    scopus 로고
    • Process analytical technology (PAT) tools for the cultivation step in biopharmaceutical production
    • Streefland M., et al. Process analytical technology (PAT) tools for the cultivation step in biopharmaceutical production. Eng. Life Sci. 2013, 13:212-223.
    • (2013) Eng. Life Sci. , vol.13 , pp. 212-223
    • Streefland, M.1
  • 19
    • 70349949073 scopus 로고    scopus 로고
    • Advances in on-line monitoring and control of mammalian cell cultures: supporting the PAT initiative
    • Teixeira A.P., et al. Advances in on-line monitoring and control of mammalian cell cultures: supporting the PAT initiative. Biotechnol. Adv. 2009, 27:726-732.
    • (2009) Biotechnol. Adv. , vol.27 , pp. 726-732
    • Teixeira, A.P.1
  • 21
    • 84864747791 scopus 로고    scopus 로고
    • A new era in cell culture media development
    • Grosvenor S. A new era in cell culture media development. BioPharm Int. 2012, 25:28-35.
    • (2012) BioPharm Int. , vol.25 , pp. 28-35
    • Grosvenor, S.1
  • 22
    • 79954419863 scopus 로고    scopus 로고
    • Chemometrics applications in biotech processes: a review
    • Rathore A.S., et al. Chemometrics applications in biotech processes: a review. Biotechnol. Prog. 2011, 27:307-315.
    • (2011) Biotechnol. Prog. , vol.27 , pp. 307-315
    • Rathore, A.S.1
  • 23
    • 33644686538 scopus 로고    scopus 로고
    • The process analytical technology initiative and multivariate process analysis, monitoring and control
    • Kourti T. The process analytical technology initiative and multivariate process analysis, monitoring and control. Anal. Bioanal. Chem. 2006, 384:1043-1048.
    • (2006) Anal. Bioanal. Chem. , vol.384 , pp. 1043-1048
    • Kourti, T.1
  • 24
    • 22544459113 scopus 로고    scopus 로고
    • Process analytical technology and multivariate statistical process control. Index of wellness of product and process. Part 1
    • Kourti T. Process analytical technology and multivariate statistical process control. Index of wellness of product and process. Part 1. Process Anal. Technol. 2004, 1:13-19.
    • (2004) Process Anal. Technol. , vol.1 , pp. 13-19
    • Kourti, T.1
  • 25
    • 0029703047 scopus 로고    scopus 로고
    • Experiences with industrial applications of projection methods for multivariate statistical process control
    • Kourti T., et al. Experiences with industrial applications of projection methods for multivariate statistical process control. Comp. Chem. Eng. 1996, 20(Suppl. 1):S745-S750.
    • (1996) Comp. Chem. Eng. , vol.20 , Issue.SUPPL. 1
    • Kourti, T.1
  • 26
    • 0026108818 scopus 로고
    • Multivariate statistical monitoring of process operating performance
    • Kresta J.V., et al. Multivariate statistical monitoring of process operating performance. Can. J. Chem. Eng. 1991, 69:35-47.
    • (1991) Can. J. Chem. Eng. , vol.69 , pp. 35-47
    • Kresta, J.V.1
  • 27
    • 0028483476 scopus 로고
    • Monitoring batch processes using multiway principal component analysis
    • Nomikos P., MacGregor J.F. Monitoring batch processes using multiway principal component analysis. AIChE J. 1994, 40:1361-1375.
    • (1994) AIChE J. , vol.40 , pp. 1361-1375
    • Nomikos, P.1    MacGregor, J.F.2
  • 28
    • 0028825273 scopus 로고
    • Multi-way partial least squares in monitoring batch processes
    • Nomikos P., MacGregor J.F. Multi-way partial least squares in monitoring batch processes. Chemometr. Intell. Lab. 1995, 30:97-108.
    • (1995) Chemometr. Intell. Lab. , vol.30 , pp. 97-108
    • Nomikos, P.1    MacGregor, J.F.2
  • 29
    • 0010040681 scopus 로고
    • Multi-way principal components- and PLS-analysis
    • Wold S., et al. Multi-way principal components- and PLS-analysis. J. Chemometrics 1987, 1:41-56.
    • (1987) J. Chemometrics , vol.1 , pp. 41-56
    • Wold, S.1
  • 30
    • 33847075819 scopus 로고    scopus 로고
    • Multivariate analysis of ground water and soil data from a waste disposal site
    • Mumford K.G., et al. Multivariate analysis of ground water and soil data from a waste disposal site. Ground Water Monit. Remed. 2007, 27:92-102.
    • (2007) Ground Water Monit. Remed. , vol.27 , pp. 92-102
    • Mumford, K.G.1
  • 31
    • 77958608859 scopus 로고    scopus 로고
    • Polymerization online monitoring
    • Frauendorfer E., et al. Polymerization online monitoring. Chem. Eng. Technol. 2010, 33:1767-1778.
    • (2010) Chem. Eng. Technol. , vol.33 , pp. 1767-1778
    • Frauendorfer, E.1
  • 32
    • 3242731248 scopus 로고    scopus 로고
    • An industrial perspective on implementing on-line applications of multivariate statistics
    • Miletic I., et al. An industrial perspective on implementing on-line applications of multivariate statistics. J. Process Control 2004, 14:821-836.
    • (2004) J. Process Control , vol.14 , pp. 821-836
    • Miletic, I.1
  • 33
    • 19644362083 scopus 로고    scopus 로고
    • IR spectroscopy together with multivariate data analysis as a process analytical tool for in-line monitoring of crystallization process and solid-state analysis of crystalline product
    • Pöllänen K., et al. IR spectroscopy together with multivariate data analysis as a process analytical tool for in-line monitoring of crystallization process and solid-state analysis of crystalline product. J. Pharm. Biomed. Anal. 2005, 38:275-284.
    • (2005) J. Pharm. Biomed. Anal. , vol.38 , pp. 275-284
    • Pöllänen, K.1
  • 34
    • 33144488961 scopus 로고    scopus 로고
    • Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement
    • Scott B., Wilcock A. Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement. PDA J. Pharm. Sci. Technol. 2006, 60:17-53.
    • (2006) PDA J. Pharm. Sci. Technol. , vol.60 , pp. 17-53
    • Scott, B.1    Wilcock, A.2
  • 35
    • 70350208809 scopus 로고    scopus 로고
    • Quality by design case study: an integrated multivariate approach to drug product and process development
    • Huang J., et al. Quality by design case study: an integrated multivariate approach to drug product and process development. Int. J. Pharm. 2009, 382:23-32.
    • (2009) Int. J. Pharm. , vol.382 , pp. 23-32
    • Huang, J.1
  • 36
    • 79953678087 scopus 로고    scopus 로고
    • Process analytical technology (PAT) for biopharmaceuticals
    • Glassey J., et al. Process analytical technology (PAT) for biopharmaceuticals. Biotechnol. J. 2011, 6:369-377.
    • (2011) Biotechnol. J. , vol.6 , pp. 369-377
    • Glassey, J.1
  • 37
    • 8444230152 scopus 로고    scopus 로고
    • Chemometrics in bioprocess engineering: process analytical technology (PAT) applications
    • Lopes J.A., et al. Chemometrics in bioprocess engineering: process analytical technology (PAT) applications. Chemometr. Intell. Lab. 2004, 74:269-275.
    • (2004) Chemometr. Intell. Lab. , vol.74 , pp. 269-275
    • Lopes, J.A.1
  • 38
    • 84867350799 scopus 로고    scopus 로고
    • Chemometrics applications in biotechnology processes: predicting column integrity and impurity clearance during reuse of chromatography resin
    • Rathore A.S., et al. Chemometrics applications in biotechnology processes: predicting column integrity and impurity clearance during reuse of chromatography resin. Biotechnol. Prog. 2012, 28:1308-1314.
    • (2012) Biotechnol. Prog. , vol.28 , pp. 1308-1314
    • Rathore, A.S.1
  • 39
    • 78649410389 scopus 로고    scopus 로고
    • Improved process analytical technology for protein a chromatography using predictive principal component analysis tools
    • Hou Y., et al. Improved process analytical technology for protein a chromatography using predictive principal component analysis tools. Biotechnol. Bioeng. 2011, 108:59-68.
    • (2011) Biotechnol. Bioeng. , vol.108 , pp. 59-68
    • Hou, Y.1
  • 40
    • 0037079054 scopus 로고    scopus 로고
    • Computational systems biology
    • Kitano H. Computational systems biology. Nature 2002, 420:206-210.
    • (2002) Nature , vol.420 , pp. 206-210
    • Kitano, H.1
  • 41
    • 84862307869 scopus 로고    scopus 로고
    • Systems biotechnology of animal cells: the road to prediction
    • Carinhas N., et al. Systems biotechnology of animal cells: the road to prediction. Trends Biotechnol. 2012, 30:377-385.
    • (2012) Trends Biotechnol. , vol.30 , pp. 377-385
    • Carinhas, N.1
  • 42
    • 79951674715 scopus 로고    scopus 로고
    • High-throughput process development for biopharmaceutical drug substances
    • Bhambure R., et al. High-throughput process development for biopharmaceutical drug substances. Trends Biotechnol. 2011, 29:127-135.
    • (2011) Trends Biotechnol. , vol.29 , pp. 127-135
    • Bhambure, R.1
  • 43
    • 34547874307 scopus 로고    scopus 로고
    • Fault detection and diagnosis in an industrial fed-batch cell culture process
    • Gunther J.C., et al. Fault detection and diagnosis in an industrial fed-batch cell culture process. Biotechnol. Prog. 2007, 23:851-857.
    • (2007) Biotechnol. Prog. , vol.23 , pp. 851-857
    • Gunther, J.C.1
  • 44
    • 77955475972 scopus 로고    scopus 로고
    • Monitoring bioreactors using principal component analysis: production of penicillin G acylase as a case study
    • Nucci E.R., et al. Monitoring bioreactors using principal component analysis: production of penicillin G acylase as a case study. Bioprocess Biosyst. Eng. 2010, 33:557-564.
    • (2010) Bioprocess Biosyst. Eng. , vol.33 , pp. 557-564
    • Nucci, E.R.1
  • 45
    • 33847173754 scopus 로고    scopus 로고
    • Application of multivariate analysis toward biotech processes: case study of a cell-culture unit operation
    • Kirdar A.O., et al. Application of multivariate analysis toward biotech processes: case study of a cell-culture unit operation. Biotechnol. Prog. 2007, 23:61-67.
    • (2007) Biotechnol. Prog. , vol.23 , pp. 61-67
    • Kirdar, A.O.1
  • 46
    • 45149094660 scopus 로고    scopus 로고
    • Application of multivariate data analysis for identification and successful resolution of a root cause for a bioprocessing application
    • Kirdar A.O., et al. Application of multivariate data analysis for identification and successful resolution of a root cause for a bioprocessing application. Biotechnol. Prog. 2008, 24:720-726.
    • (2008) Biotechnol. Prog. , vol.24 , pp. 720-726
    • Kirdar, A.O.1
  • 47
    • 77956245938 scopus 로고    scopus 로고
    • Multivariate data analysis on historical IPV production data for better process understanding and future improvements
    • Thomassen Y.E., et al. Multivariate data analysis on historical IPV production data for better process understanding and future improvements. Biotechnol. Bioeng. 2010, 107:96-104.
    • (2010) Biotechnol. Bioeng. , vol.107 , pp. 96-104
    • Thomassen, Y.E.1
  • 48
    • 84881512365 scopus 로고    scopus 로고
    • Multivariate data analysis as a PAT tool for early bioprocess development data
    • Mercier S., et al. Multivariate data analysis as a PAT tool for early bioprocess development data. J. Biotechnol. 2013, 167:262-270.
    • (2013) J. Biotechnol. , vol.167 , pp. 262-270
    • Mercier, S.1
  • 49
    • 0037142415 scopus 로고    scopus 로고
    • An assessment of seed quality and its influence on productivity estimation in an industrial antibiotic fermentation
    • Cunha C.C.F., et al. An assessment of seed quality and its influence on productivity estimation in an industrial antibiotic fermentation. Biotechnol. Bioeng. 2001, 78:658-669.
    • (2001) Biotechnol. Bioeng. , vol.78 , pp. 658-669
    • Cunha, C.C.F.1
  • 50
    • 84868481008 scopus 로고    scopus 로고
    • Multivariate analysis of cell culture bioprocess data - lactate consumption as process indicator
    • Le H., et al. Multivariate analysis of cell culture bioprocess data - lactate consumption as process indicator. J. Biotechnol. 2012, 162:210-223.
    • (2012) J. Biotechnol. , vol.162 , pp. 210-223
    • Le, H.1
  • 51
    • 78349281210 scopus 로고    scopus 로고
    • Mining manufacturing data for discovery of high productivity process characteristics
    • Charaniya S., et al. Mining manufacturing data for discovery of high productivity process characteristics. J. Biotechnol. 2010, 147:186-197.
    • (2010) J. Biotechnol. , vol.147 , pp. 186-197
    • Charaniya, S.1
  • 52
    • 55449125185 scopus 로고    scopus 로고
    • Support vector machines and kernels for computational biology
    • Ben-Hur A., et al. Support vector machines and kernels for computational biology. PLoS Comput. Biol. 2008, 4:e1000173.
    • (2008) PLoS Comput. Biol. , vol.4
    • Ben-Hur, A.1
  • 53
    • 60549109858 scopus 로고    scopus 로고
    • In situ 2D fluorometry and chemometric monitoring of mammalian cell cultures
    • Teixeira A.P., et al. In situ 2D fluorometry and chemometric monitoring of mammalian cell cultures. Biotechnol. Bioeng. 2009, 102:1098-1106.
    • (2009) Biotechnol. Bioeng. , vol.102 , pp. 1098-1106
    • Teixeira, A.P.1
  • 54
    • 79955590003 scopus 로고    scopus 로고
    • Process control in cell culture technology using dielectric spectroscopy
    • Justice C., et al. Process control in cell culture technology using dielectric spectroscopy. Biotechnol. Adv. 2011, 29:391-401.
    • (2011) Biotechnol. Adv. , vol.29 , pp. 391-401
    • Justice, C.1
  • 55
    • 34250815100 scopus 로고    scopus 로고
    • Study of the application of multiway multivariate techniques to model data from an industrial fermentation process. Papers Presented at the 10th International Conference on Chemometrics in Analytical Chemistry CAC 2006
    • Ferreira A.P., et al. Study of the application of multiway multivariate techniques to model data from an industrial fermentation process. Papers Presented at the 10th International Conference on Chemometrics in Analytical Chemistry CAC 2006. Anal. Chim. Acta 2007, 595:120-127.
    • (2007) Anal. Chim. Acta , vol.595 , pp. 120-127
    • Ferreira, A.P.1
  • 56
    • 80054837888 scopus 로고    scopus 로고
    • On-line monitoring of recombinant bacterial cultures using multi-wavelength fluorescence spectroscopy
    • Jain G., et al. On-line monitoring of recombinant bacterial cultures using multi-wavelength fluorescence spectroscopy. Biochem. Eng. J. 2011, 58-59:133-139.
    • (2011) Biochem. Eng. J. , pp. 133-139
    • Jain, G.1
  • 57
    • 79953152705 scopus 로고    scopus 로고
    • Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe
    • Abu-Absi N.R., et al. Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe. Biotechnol. Bioeng. 2010, 108:1215-1221.
    • (2010) Biotechnol. Bioeng. , vol.108 , pp. 1215-1221
    • Abu-Absi, N.R.1
  • 58
    • 84885050930 scopus 로고    scopus 로고
    • Monitoring mammalian cell cultivations for monoclonal antibody production using near-infrared spectroscopy
    • Henriques J.G., et al. Monitoring mammalian cell cultivations for monoclonal antibody production using near-infrared spectroscopy. Adv. Biochem. Eng. Biotechnol. 2009, 116:29-72.
    • (2009) Adv. Biochem. Eng. Biotechnol. , vol.116 , pp. 29-72
    • Henriques, J.G.1
  • 59
    • 10644262099 scopus 로고    scopus 로고
    • On-line multi-analyzer monitoring of biomass, glucose and acetate for growth rate control of a Vibrio cholerae fed-batch cultivation
    • Navrátil M., et al. On-line multi-analyzer monitoring of biomass, glucose and acetate for growth rate control of a Vibrio cholerae fed-batch cultivation. J. Biotechnol. 2005, 115:67-79.
    • (2005) J. Biotechnol. , vol.115 , pp. 67-79
    • Navrátil, M.1
  • 60
    • 79955831603 scopus 로고    scopus 로고
    • Process Raman spectroscopy for in-line CHO cell culture monitoring
    • Moretto J., et al. Process Raman spectroscopy for in-line CHO cell culture monitoring. Am. Pharm. Rev. 2011, 14:18-25.
    • (2011) Am. Pharm. Rev. , vol.14 , pp. 18-25
    • Moretto, J.1
  • 61
    • 73249118965 scopus 로고    scopus 로고
    • Application of near-infrared spectroscopy for monitoring and control of cell culture and fermentation
    • Cervera A.E., et al. Application of near-infrared spectroscopy for monitoring and control of cell culture and fermentation. Biotechnol. Prog. 2009, 25:1561-1581.
    • (2009) Biotechnol. Prog. , vol.25 , pp. 1561-1581
    • Cervera, A.E.1
  • 62
    • 84876268622 scopus 로고    scopus 로고
    • Chemometrics and in-line near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell culture: prediction of multiple cultivation variables
    • Clavaud M., et al. Chemometrics and in-line near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell culture: prediction of multiple cultivation variables. Talanta 2013, 111:28-38.
    • (2013) Talanta , vol.111 , pp. 28-38
    • Clavaud, M.1
  • 63
    • 70349322632 scopus 로고    scopus 로고
    • A practical approach for exploration and modeling of the design space of a bacterial vaccine cultivation process
    • Streefland M., et al. A practical approach for exploration and modeling of the design space of a bacterial vaccine cultivation process. Biotechnol. Bioeng. 2009, 104:492-504.
    • (2009) Biotechnol. Bioeng. , vol.104 , pp. 492-504
    • Streefland, M.1


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