Predicting MAb Product Yields from Cultivation Media Components Using NIR Spectroscopy

Jose G.E. Folque F. Menezes J.C. Werz S. Strauss U. Hakemeyer C. , “Predicting Mab product yields from cultivation media components, using near infrared and 2D-fluorescence spectroscopy”, Biotechnol. Prog. 27, 1339–1346 (2011). doi: 10.1002/btpr.638

Roggo Y. Chalus P. Maurer L. Lema-Martinez C. Edmond A. Jent N. , “A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies”, J. Pharm. Biomed. Anal. 44, 683–700 (2007). doi: 10.1016/j.jpba.2007.03.023

Roychoudhury P. Harvey L.M. McNeil B. , “The potential of mid infrared spectroscopy (MIRS) for real time bioprocess monitoring”, Anal. Chim. Acta 571, 159–166 (2006). doi: 10.1016/j.aca.2006.04.086

Luo Y. Chen G. , “Combined approach of NMR and chemometrics for screening peptones used in the cell culture medium for the production of recombinant therapeutic protein”, Biotechnol. Bioeng. 97, 1654–1659 (2007). doi: 10.1002/bit.21365

Lanan M. , “QbD for raw materials”, in Quality by Design for Biopharmaceuticals: Principles and Case Studies, Ed by Rathore A.S. Mhatre R. , Wiley, pp. 193–209 (2009). doi: 10.1002/9780470466315.ch11

Boyan L. Ryan P. Bryan R. Leister K. Sirimuthu N. Ryder A. , “Rapid characterisation and quality control of complex cell culture media using Raman spectroscopy and chemometrics”, Biotechnol. Bioeng. 107, 290–301 (2010). doi: 10.1002/bit.22813

Skibsted E. , “PAT applied to pharmaceutical raw materials”, in Process Analytical Technology Applied in Biopharmaceutical Process Development and Manufacturing: Enabling Tool for Quality-by-Design, Ed by Undey C. Low D. Menezes J.C. Koch M. , Taylor & Francis, Chapter 7 (2011). doi: 10.1201/b11536-8

Geladi P. Kowalski B.R. , “Partial least squares regression: A tutorial”, Anal. Chim. Acta 185, 1–17 (1986). doi: 10.1016/0003-2670(86)80028-9

Bakeev K.A. , Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries (2nd edition). Wiley (2010). doi: 10.1002/9780470689592

Kirdar A. Chen G. Weidner J. Rathore A. , “Combining near-infrared (NIR) spectroscopy with multivariate data analysis (MVDA) for screening of raw materials used in the cell culture medium for the production of a recombinant therapeutic protein”, Biotechnol. Prog. 26, 527–531 (2009).

Galvão R. Araúp M. José G.E. Pontes M.J. Silva E. Saldanha T.C. , “A method for calibration and validation subset partitioning”, Talanta 67, 736–740 (2005). doi: 10.1016/j.talanta.2005.03.025