Process Analytical Technology (PAT) Initiative: Literature References

Process Analytical Technology (PAT) Initiative

Literature References

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Yu, LX, Lionberger, RA, Rawa, AS, D'Costa, R, Wu, H, Hussain, AS. Applications of Process Analytical Technology to Crystallization Processes. Center for Drug Evaluation and Research, Food and Drug Administration. 8/2003.

Gunnell, JJ, van Vuuren, P. Process analytical systems: a vision for the future. Journal of Process Analytical Chemistry; 6(1)

McGill, CA, Alison Nordon, A, Littlejohn, D. Potential applications of process analytical analysis by NMR spectrometry. Journal of Process Analytical Chemistry; 6(1).

Creasy, KE. Process analytical chemistry...smarter, faster, stronger. Journal of Process Analytical Chemistry; 7(1).

Farquharson, S, Smith, W, Rose, J, Shaw, M. Correlations between molecular (Raman) and macroscopic (Rheology) data for process monitoring of thermoset composites. Journal of Process Analytical Chemistry; 7(2).

Clarke, FC; Hammon, SV; Mattisson, C. The development of NIR microscopy for process control in pharmaceutical manufacturing. Journal of Process Analytical Chemistry; 7(3).

Webster, GK, Farrand, DA; and Litchman, MA. A chemical sensor based scheme to evaluate packaging containment effectiveness - Part 1: Development and optimization. Journal of Process Analytical Chemistry, 8(1).

Workman, J. Jr.; Creasy, K. E.; Doherty, S.; Bond, L.; Koch, M.; Ullman, A.; Veltkamp, D. J. Process Analytical Chemistry. Anal. Chem. 2001; 73(12); 2705-2718.

Workman, J., Jr.; Veltkamp, D. J.; Doherty, S.; Anderson, B. B.; Creasy, K. E.; Koch, M.; Tatera, J. F.; Robinson, A. L.; Bond, L.; Burgess, L. W.; Bokerman, G. N.; Ullman, A. H.; Darsey, G. P.; Mozayeni, F.; Bamberger, J. A.; Greenwood, M. S. Process Analytical Chemistry. Anal. Chem. (Review); 1999; 71(12); 121-180.

Watano S, Numa T, Koizumi I, Osako Y. Feedback control in high shear granulation of pharmaceutical powders. Eur J Pharm Biopharm. 2001 Nov; 52(3):337-45.

Watano, S., Numa, T., Miyanami, K.,Osako, Y. A fuzzy control system of high shear granulation using image processing. Powder Technology, 115, 124-130, 2001.

Frake, P, Greenhalgh, D., Grierson, SM, Hempenstall, JM and Rudd, DR. Process control and end-point determination of a fluid bed granulation by application of near infra-red spectroscopy, International Journal of Pharmaceutics, 151, 75-80, 1997.

Westerhuis, JA, Coenegracht, PMJ, and Lerk, CF. Multivariate modelling of the tablet manufacturing process with wet granulation for tablet optimization and in-process control, International Journal of Pharmaceutics, 156, 109-117, 1997.

Morisseau KM, Rhodes CT. Near-infrared spectroscopy as a nondestructive alternative to conventional tablet hardness testing. Pharm Res. 1997 Jan;14(1):108-11.

Leuenberger, H., Scale-up in the 4th dimension in the field of granulation and drying or how to avoid classical scale-up. Powder Technology, 130, 225-230, 2003.

Gold TB, Buice RG Jr, Lodder RA, Digenis GA. Determination of extent of formaldehyde-induced crosslinking in hard gelatin capsules by near-infrared spectrophotometry. Pharm Res. 1997 Aug;14(8):1046-50.

O'Neil AJ, Jee RD, Moffat AC. Measurement of the cumulative particle size distribution of microcrystalline cellulose using near infrared reflectance spectroscopy. Analyst. 1999 Jan;124(1):33-6.

Hamilton SJ, Lowell AE, Lodder RA. Hyperspectral techniques in analysis of oral dosage forms. J Biomed Opt. 2002 Oct;7(4):561-70.

Rantanen J, Rasanen E, Tenhunen J, Kansakoski M, Mannermaa J, Yliruusi J. In-line moisture measurement during granulation with a four-wavelength near infrared sensor: an evaluation of particle size and binder effects. Eur J Pharm Biopharm. 2000 Sep;50(2):271-6.

Kirsch JD, Drennen JK. Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm. J Pharm Biomed Anal. 1999 Mar;19(3-4):351-62.

O'Neil AJ, Jee RD, Moffat AC. The application of multiple linear regression to the measurement of the median particle size of drugs and pharmaceutical excipients by near-infrared spectroscopy. Analyst. 1998 Nov;123(11):2297-302.

Otsuka M, Kato F, Matsuda Y. Comparative evaluation of the degree of indomethacin crystallinity by chemoinfometrical Fourier-transformed [corrected] near-infrared spectroscopy and conventional powder X-ray diffractometry. AAPS PharmSci. 2000;2(1):E9.

Harthun S, Matischak K, Friedl P. Determination of recombinant protein in animal cell culture supernatant by near-infrared spectroscopy. Anal Biochem. 1997 Aug 15;251(1):73-8.

Yeung KS, Hoare M, Thornhill NF, Williams T, Vaghjiani JD. Near-infrared spectroscopy for bioprocess monitoring and control. Biotechnol Bioeng. 1999 Jun 20;63(6):684-93.

Lin TP, Hsu CC. Determination of residual moisture in lyophilized protein pharmaceuticals using a rapid and non-invasive method: near infrared spectroscopy. PDA J Pharm Sci Technol. 2002 Jul-Aug;56(4):196-205.

Patel AD, Luner PE, Kemper MS. Low-level determination of polymorph composition in physical mixtures by near-infrared reflectance spectroscopy. J Pharm Sci. 2001 Mar;90(3):360-70.

Buchacher A, Schulz P, Choromanski J, Schwinn H, Josic D. High-performance capillary electrophoresis for in-process control in the production of antithrombin III and human clotting factor IX. J Chromatogr A. 1998 Apr 10;802(2):355-66.

Reif OW, Freitag R. Control of the cultivation process of antithrombin III and its characterization by capillary electrophoresis. J Chromatogr A. 1994 Oct 7;680(2):383-94.

Strege MA, Lagu AL. Capillary electrophoresis of biotechnology-derived proteins. Electrophoresis. 1997 Nov;18(12-13):2343-5.

Higgins JP, Arrivo SM, Thurau G, Green RL, Bowen W, Lange A, Templeton AC, Thomas DL, Reed RA. Spectroscopic approach for on-line monitoring of particle size during the processing of pharmaceutical nanoparticles. Anal Chem. 2003 Apr 15;75(8):1777-85.

Liu Y, Wang F, Lee W. On-line monitoring and controlling system for fermentation processes. Biochem. Eng. J. 2001 Jan;7(1):17-25.

Cimander C, Bachinger T, Mandenius CF. Integration of distributed multi-analyzer monitoring and control in bioprocessing based on a real-time expert system. J Biotechnol. 2003 Aug 15;103(3):237-48.

Groth T, Moden H. Related Articles, A knowledge-based system for real-time quality control and fault diagnosis of multitest analyzers. Comput Methods Programs Biomed. 1991 Feb-Mar;34(2-3):175-90.

Date created: September 12, 2003