Therapeutics
References 1 Fierce Pharma. (2018) Special report – Herceptin. [ONLINE] Available at:
https://www.fiercepharma.com/special- report/herceptin-1. [Accessed 15 January 2018]. 2 Fierce Pharma. (2018) Special report- Humira. [ONLINE] Available at:
https://www.fiercepharma.com/special- report/humira. [Accessed 15 January 2018]. 3 Fierce Pharma. (2018) Special report- Avastin [ONLINE] Available at:
https://www.fiercepharma.com/special- report/avastin-1. [Accessed 15 January 2018]. 4 Ashton Acton Q. (2013). Antibodies – Advances in Research and Application: 2013 Edition. Atlanta, Georgia: Scholarly Editions. 5 DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20(11):1885-1900. 6 Nowatzke, W, Woolf, E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J. 2007;9(2):E117-E122. 7 Rup, B, O’Hara, D. Critical ligand binding reagent preparation/selection: when specificity depends on reagents. AAPS J. 2007;9(1):E148- E155. 8 King, LE, Farley, E, Imazato, M, Keefe, J, Khan, M, Ma, M, Pihl, S, Sriraman, P. Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team. 2014;16(3):504-515. 9Ylera, F, Harth, S, Waldherr, D, Frisch, C, Knappik, A. Off-rate screening for selection of high-affinity anti-drug antibodies. Anal. Biochem. 2013;441(2): 208-213. 10 Chin, SE, Ferraro, F, Groves, M, Liang, M, Vaughan, TJ, Dobson, CL. Isolation of high- affinity, neutralizing anti-idiotype antibodies by phage and ribosome display for application in immunogenicity and pharma-cokinetic analyses. J Immunol. Methods. 2015;416: 49-58. 11 Geist, BJ, Egan, AC, Yang, TY, Dong, Y, Shankar, G. Characterization of critical reagents in ligand- binding assays: enabling robust bioanalytical methods and lifecycle management. 2013;5(2):227-244. 12 O’Hara, DM, Theobald, V. Life cycle management of critical ligand-binding reagents. 2013;5(21):2679-2696. 13 US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine Guidance for industry: bioanalytical method validation. Fed Regist. 2001;66(100):28526.
14 European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 21 Jul 2011. 15 Clinical Laboratory Standards Institute (Formerly NCCLS). Assessing the quality of immunoassay systems: radioimmunoassays and enzyme, fluorescence, and luminescence immunoassays; approved guideline. NCCLS I/LA23-A 2004;24 (16). 16 Arnold, M, Fluhler, E, Gorovits, B. Understanding Bioanalysis Regulations. 2017 In: Rocci Jr, ML, Lowes, S. (Ed.) Regulated Bioanalysis: Fundamentals and Practice (pp. 15- 38) Gewerbestrasse, Switzerland: Springer International Publishing. 17 Global Bioanalytical Consortium. [cited January 3, 2018]. Available from:
http://www.globalbioanalysis
consortium.org/. 18 Ko Ferrigno, P, McLeod, J. Restructuring proteomics: The rise of next generation affinity reagents. DDW. Winter 2014. 19 O’Hara, DM, Theobald, V, Clements Eqan, A, Usansky, J, Krishna, M, TerWee, J, Maia, M, Spriggs, FP et al. Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents. 2012;14(2):316-328. 20 Bradbury, A, Plückthun, A. Reproducibility: Standardize antibodies used in research. Nature. 2015:27-29. 21 Bayer, M. Reproducibility crisis: Blame it on the antibodies. Nature. 2015:274-276. 22 Bio-Rad. HuCal Antibodies Technical Manual. HuCal Technology. Available at:
https://www.bio-
rad-antibodies.com/static/2016/hucal-technical- manual/hucal-technical-manual-technology.pdf. [Accessed 15 January 2018]. 23 Tiede, C, Bedford, R, Heseltine, SJ, Smith, G, Wijetunga, I, Ross, R, Al Quallaf, D, Roberts, APE et al. Affimer proteins are versatile and renewable affinity reagents. eLife 2017;e24903.
14
Drug Discovery World Winter 2017/18
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72
