Publications
Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing? Laura I. Salazar-Fontana, Ph.D., and Daniela Drago, Ph.D., RAC, NDA Partners. BioProcess Online, Guest Column, May 21, 2024
2024
Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals. MAbs. 2024 Jan-Dec;16(1):2324801. Epub 2024 Mar 5. Tourdot S, Baltrunkonis D, Denies S, Devanarayan V, Grudzinska-Goebel J, Kromminga A, Lotz GP, Malherbe L, Michaut L, Weldingh KN, Pedras-Vasconcelos JA, Salazar-Fontana LI, Spindeldreher S, Sauna Z, Snoeck V, Verthelyi D, Kramer D.
2024
Drug Development for Gene Therapy: Translational Biomarkers, Bioanalysis, and Companion Diagnostics. Lu, Y and Gorovitz, B. 2024-02-09, Wiley Professional, Reference & Trade. Available from: vbk://9781119852803. Current Regulatory Landscape for Gene Therapy Product Development Authors: Laura I. Salazar-Fontana, PhD and Michael Havert, PhD
2024
A regulatory risk-based approach to the development of ATMP/CGT: integrating scientific challenges with current regulatory expectations and pathways. Frontiers in Medicine, Research Topic : Global Excellence in Gene and Cell Therapy: Europe , 13 May 2022. Laura I. Salazar-Fontana, PhD
2022
Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development. AAPS Journal 2017; 19(2):377-385. Salazar-Fontana LI, Desai DD, Khan TA, Pillutla RC, Prior S, Ramakrishnan R, Schneider J, Joseph A.
2017
Pre-existing Antibody: Biotherapeutic Modality-Based Review. AAPS Journal, 2016, 18(2): 311-20. Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L.
2016
2015
2014