Further reading Books

Aguilar, M. 2003. HPLC of Peptides and Proteins. Humana Press.

Dass, C. 2000. Principles and Practice of Biological Mass Spectrometry. Wiley.

Kellner, R. 1999. Micorcharacterization of Proteins. Wiley.

Kinter, M. and Sherman, N. 2005. Protein Sequencing and Identification Using Tandem Mass Spectrometry. Wiley.

Ramstorp, M. 2000. Contamination Control and Cleanroom Technology. Wiley.

Rathore, A. and Sofer, G. (eds). 2005. Process Validation in Manufacturing of Biopharmaceuticals: Guidelines,

Current Practices, and Industrial Case Studies. Taylor and Francis. Rosenberg, I. 2004. Protein Analysis and Purification. Birkhauser. Venn, R. 2000. Principles and Practice of Bioanalysis. Taylor and Francis. Whyte, W. 2001. Cleanroom Technology. Wiley. Wild, D. (ed.) 2005. The Immunoassay Handbook. Elsevier.

Articles

Dabbah, R. and Grady, L. 1998. Pharmacopoeial harmonization in biotechnology. Current Opinion in Biotechnology 9, 307-311.

Darling, A. 2002. Validation of biopharmaceutical purification processes for virus clearance evaluation. Molecular Biotechnology 21, 57-83.

Ding, J. and Ho, B. 2001. A new era in pyrogen testing. Trends in Biotechnology 18(8), 277-280.

Domon, B. and Aebersold, R. 2006. Review - mass spectrometry and protein analysis. Science 312, 212-217.

Geisow, M.J. 1991. Characterizing recombinant proteins. Bio/Technology 9, 921-924.

Geng, D., Shankar, G., Schantz, A., Rajadhyaksha, M., Davis, H., and Wagner, C. 2005. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. Journal of Pharmaceutical and Biomedical Analysis 39, 364-375.

Glennon, B. 1997. Control system validation in multipurpose biopharmaceutical facilities. Journal of Biotechnology 59(1-2), 53-61.

Hu, S. and Dovichi, N. 2002. Capillary electrophoresis for the analysis of biopolymers. Analytical Chemistry 74 (12), 2833-2850.

Kakehi, K., Kinoshita, M., and Nakano, M. 2002. Analysis of glycoproteins and the oligosaccharides thereof by high performance capillary electrophoresis - significance in regulatory studies on biopharmaceutical products. Biomedical Chromatography 16(2), 103-115.

Kett, V., McMahon, D., and Ward, K. 2004. Freeze-drying of protein pharmaceuticals - the application of thermal analysis. Cryoletters 25, 389-404.

Larsen, M.R., Trelle, M.B., Thingholm, T.E., and Jensen, O.N. 2006. Analysis of posttranslational modifications of proteins by tandem mass spectrometry. BioTechniques 40, 790-798.

Lin, S. and Hsu, S. 2005. Recent advances in capillary electrophoresis immunoassays. Analytical Biochemistry 341, 1-15.

Mann, M., Hendrickson, R.C., and Pandey, A. 2001. Analysis of proteins and proteomes by mass spectrometry. Annual Review of Biochemistry 70, 437-473.

Meager, A. 2006. Measurement of cytokines by bioassays: theory and applications. Methods 38, 237-252.

Raetz, C. and Whitfield, C. 2002. Lipopolysaccharide endotoxins. Annual Review of Biochemistry 71, 635-700.

Seamon, K. 1998. Specifications for biotechnology-derived protein drugs. Current Opinion in Biotechnology 9, 319-325.

Chew, N. 1993. Validation of biopharmaceutical processes. Pharmaceutical Technology Europe, 5(11), 34-39.

Tatford, O.C., Gomme, P.T., and Bertolini, J. 2004. Analytical techniques for the evaluation of liquid protein therapeutics. Biotechnology and Applied Biochemistry 40, 67-81.

Tumanov, A. and Krestyaninov, P. 2002. Current status and prospects of bioassay. Journal of Analytical Chemistry 57, 372-387.

Wuhrer, M., Koeleman, C.A., Hokke, C.H., and Deelder, A.M. 2005. Protein glycosylation analysis by liquid chromatography-mass spectrometry. Journal of Chromatography B 825, 124-133.

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