REFERENCES
1. 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). PAT guidance for industry—A framework for
innovative pharmaceutical development, manufacturing and quality assurance. 2004 September; p. 7.
2. Scott B, and Wilcock A. Process analytical technology in the pharmaceutical industry: A toolkit for continuous improvement.
PDA Journal of Pharmaceutical Science and Technology 2006; 60(1): 17–53.
3. Larson TM, and Lam H. Process analytical technology in biopharmaceutical production: Past successes and future challenges.
The Journal of Process Analytical Technology 2004; 1(1):20–22.
4. Larson TM, Davis J, Lam H, Cacia J. Use of process data to assess chromatographic performance in production-scale protein
purification columns, Biotechnol. Prog. 2003; (19):485–492.
5. Past articles in the "Elements of Biopharmaceutical Production" series includes:
5A. Rathore AS, Nofer JF, Arling ER, Sofer G, Watler P, and O'Leary R. Process validation: How much and when. BioPharm 2002
October; 15(10):18–28.
5B. Rathore AS, Levine H, Latham P, Curling J, and Kaltenbrunner O. Costing issues in production of biopharmaceuticals. BioPharm
2004 February; 17(2):46–55.
5C. Rathore AS, Wang A, Menon M, Riske F, Campbell J, Goodrich E, and Martin J. Optimization, scale-up and validation Issues
in filtration of biopharmaceuticals – Part I, BioPharm 2004 August; 17(8):50–58. Part II, BioPharm 2004 September; 17(9):42–50.
5D. Rathore AS, Krishnan R, Tozer S, Rausch S, and Seely J. Optimization, guidelines and examples for scale-down of biopharmaceutical
unit operations, – Part I. BioPharm 2005 March; 18(3):60–68. Part II. BioPharm 2005 April; 18(4):58-64.
5E. Moscariello J, Lightfoot E, and Rathore AS. Efficiency measurements for chromatography columns. BioPharm 2005 August;
19(8):58–64.
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