Issue link: https://resources.nanotempertech.com/i/1267034
1. G. Thiagarajan et al., A comparison of biophysical characterization techniques in predicting monoclonal antibody stability, MAb, 8(6):1088-1097, 2016. 2. E. Freire et al., Brown Chemical denaturation as a tool in the formulation optimization of biologics, Drug Discov Today, 18:1007-1013, 2013. 3. F. He et al., High throughput thermostability screening of monoclonal antibody formulations, J Pharm Sci, 99(4):1707-1720, 2010. 4. N.J. Greenfield, Using circular dichroism collected as a function of temperature to determine the thermodynamics of protein unfolding and binding interactions, Nat Protoc, 1(6): 2527-2535, 2006. 5. S.D. Jones et al., CMC Activities for Development of MAb Critical steps to reach IND with a therapeutic antibody. Accessed on 10 Dec 2019. Available online: www.contractpharma.com/ issues/2010-04/view_features/cmcactivities- for-development-of-mAb/ 6. M. Babu Medi et al., Excipient selection in biologics and vaccines formulation development, Eur Pharm Rev, issue 1, 2014. 7. T.J. Kamerzell et al., Protein-excipient interactions: Mechanisms and biophysical characterization applied to protein formulation development, Adv Drug Del Reviews, 63:1118- 1159, 2011. 8. Biopharmaceutical research and development, the process behind new medicines. The Pharmaceutical Research and Manufacturers of America, PhRMA, 2015. Accessed on 5 Feb 2020. Available online: https://www.phrma.org/ en/Report/Biopharmaceutical-R-and-D-The- Process-Behind-New-Medicines References 9. C.H. Wong et al, Estimation of clinical trial success rates and related parameters, Biostatistics, 20(2):273–286, 2019. 10. M. Herper, The cost of creating a new drug now $5 billion, pushing Big Pharmato change. Forbes, Pharma & Healthcare, 2013. Accessed on 7 Jan 2020. Available online: https://www.forbes. com/sites/matthewherper/2013/08/11/how- the-staggering-cost-of-inventing-new-drugs-is- shaping-the-future-of-medicine/ 11. T. Arakawa and D. Ejima, Refolding technologies for antibody fragments, Antibodies, 3:232-241, 2014. 12. M. Blessy et al., Development of forced degradation and stability indicating studies of drugs—A review, J Pharm Anal, 4(3):159-165, 2104. 13. Y. Akazawa-Ogawa et al., Heat denaturation of the antibody, a multi-domain protein, Biophys Rev, 10(2):255-258, 2017. 14. C. Nowak et al., Forced degradation of recombinant monoclonal antibodies: A practical guide, MAb, 9(8):1217-1230, 2017. 15. R-M. Lu et al., Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci, 27:1, 2020.