Biomedical Engineering Reference
In-Depth Information
[18] Cogdill R, Knight T, Anderson C, Drennan J. The financial returns on investments in process
analytical technology and lean manufacturing: benchmarks and case study. J Pharm Innov
2007;2:38-50.
[19] Maes I. Real-time product release based on fermentation monitoring (based on NIR) and
feed-back control. IFPAC-2005 19th International Forum Process Analytical Technology,
Arlington, VA; 2005.
[20] Fahrner R, Blank G. Real-time monitoring of recombinant antibody breakthrough during
protein A affinity chromatography. Biotechnol Appl Biochem 1999;29:109-112.
[21] Cooley R.Michigan Pharmaceutical Education Seminar. 2003, http://www.fda.gov/cder/
OPS/cooley/sld001.htm.
[22] Lee A, Webber K, Ripple D, Tarlov M, Bruce E. Future technology needs for biomanu-
facturing: special session at IFPAC 2008 identifies goals and gaps IFPAC workshop.
Biopharm Int 2008;21:12-14, also available at http://biopharminternational.findpharma.
com/biopharm/News/Future-Technology-Needs-for-Biomanufacturing-Speci/ArticleStan-
dard/Article/detail/502426?searchString ¼ ifpac.
[23] Lee A, Webber K, Ripple D, Tarlov M, Bruce E. IFPAC 2008: A Ten Year Vision for
Biotechnology Manufacturing Session. 2008. http://web.mit.edu/cbi/docs/IFPAC08_Ses-
sion%20Summary.pdf.
[24] Rathore A, Johnson R, Yu O, Kirdar A, Annamalai A, Ahuja S, Ram K. Applications of
multivariate data analysis in biotech processing. Biopharm Int 2007;20:130-134.
[25] KirdarA, Conner J, Baclaski J, RathoreA. Applicationofmulti-variateanalysis towardbiotech
processes: case study of a cell-culture unit operation. Biotechnol Prog 2007;23:61-67.
[26] Velayudhan A, Menon M. Modeling of purification operations in biotechnology: enabling
process development, optimization and scale-up. Biotech Prog 2007;23:68-73.
[27] Shukla A, Hubbard B, Tressel T, Guhan S, Low D. Downstream processing of monoclonal
antibodies: application of platform approaches. J Chromatogr B 2007;848:28-39.
[28] Pujar N, Low D, O'Leary R. Antibody purification: drivers of change in Gottschalk, U (ed)
Process Scale Purification of Antibodies Wiley & Sons, New Jersey; 2009.
[29] Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and
Control. http://www.astm.org/cgi-bin/SoftCart.exe/COMMIT/SUBCOMMIT/E5501.htm?
L þ memberstore þ npxd3610 þ 1206755405.
[30] ASTM Standard E2474-06. Standard Practice for Pharmaceutical Process Design Utilizing
Process Analytical Technology. ASTM International, West Conshohocken, PA; 2006.
[31] Lanan M. Data management and advanced monitoring of biological processes. IFPAC
Annual Meeting, Baltimore, MD; 2007.
[32] UndeyC. Data and systems management towards biopharmaceutical PAT-oriented scientific
manufacturing. ISPE Conference on Manufacturing Excellence; 2008.
[33] MoscarielloJ, HendricksonR, RydholmE, HershbergR. Arapidtechniquetoprovidereproducible
pressure-flow behaviour upon the scale-up of chromatography columns. 232nd American
Chemical Society National Conference, San Francisco, BIOT Division. Abstract 48; 2006.
[34] Wahome J, ZhouW, Kundu A. Impact of lot-to-lot variability of cation exchange chromato-
graphy resin on process performance. Biopharm Int 2008; 21:48-56, also available at http://
biopharminternational.findpharma.com/biopharm/Downstream+Processing/Impact-of-
Lot-to-Lot-Variability-of-Cation-Exchang/ArticleStandard/Article/detail/513395.
[35] Aldington S, Bonnerjea J. Scale-up of monoclonal antibody purification processes.
J Chromatogr B 2007;848:64-78.
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