PUBLICATIONS & CONTRIBUTIONS
Selected Publications & Scientific Contributions
Laura I. Salazar-Fontana, PhD
Laura has contributed extensively to the scientific community through peer-reviewed publications, conference presentations, and industry white papers, particularly in the fields of immunogenicity risk assessment and regulatory science.
2026
Lai C-H, Irving S, Salazar-Fontana LI, Grimaldi C, Gorovitz B, Partridge M. Immunogenicity in approved adeno-associated virus-based gene therapies: A framework for a tailored assessment strategy. AAPS J, 2026 (in press).
2024
Salazar-Fontana LI, Drago D. Can ICH Q14 ease regulatory risks around impurity and potency testing? BioProcess Online (Guest Column), May 21, 2024.
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. Proceedings of the 14th European Immunogenicity Platform open symposium on immunogenicity of biopharmaceuticals. MAbs, 2024; 16(1):2324801.
Salazar-Fontana LI, Havert M. Current regulatory landscape for gene therapy product development. In: Lu Y, Gorovitz B, eds. Drug Development for Gene Therapy: Translational Biomarkers, Bioanalysis, and Companion Diagnostics. Wiley, 2024.
2022
Salazar-Fontana LI. A regulatory risk-based approach to the development of ATMP/CGT: Integrating scientific challenges with current regulatory expectations and pathways. Front Med, 2022.
2017
Salazar-Fontana LI, Desai DD, Khan TA, Pillutla RC, Prior S, Ramakrishnan R, Schneider J, Joseph A. Approaches to mitigate the unwanted immunogenicity of therapeutic proteins during drug development. AAPS J, 2017; 19(2):377–385.
2016
Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L. Pre-existing antibody: Biotherapeutic modality-based review. AAPS J, 2016; 18(2):311–320.
2015
White Paper on recent issues in bioanalysis: A full immersion in bioanalysis (Part 3—LBA and immunogenicity). Bioanalysis, 2015; 7(24) and 2014; 6(24).
Annick de Vries, PhD
Annick has contributed extensively to the scientific community through peer-reviewed publications, conference presentations, and industry white papers, particularly in the fields of immunogenicity assessment, the clinical impact of immunogenicity, home sampling, and personalized dosing.
2024
Yap CF, Nair N, de Vries A, Loeff FC, Morgan AW, Isaacs JD, Wilson AG, Hyrich KL, Barton A, Plant D. HLA-DRB1 and HLA-DQA1 associated with immunogenicity to adalimumab therapy in patients with rheumatoid arthritis. Ann Rheum Dis, 2024; 83(2):263–265.
Alsoud D, Moes DJAR, Wang Z, Soenen R, Layegh Z, Barclay M, Mizuno T, Minichmayr IK, Keizer RJ, Wicha SG, Wolbink G, Lambert J, Vermeire S, de Vries A, Papamichael K, Padullés-Zamora N, Dreesen E. Best practice for therapeutic drug monitoring of infliximab. Therapeutic Drug Monitoring, 2024; 46(3):291–308.
2023
Tsakok T, Saklatvala J, Rispens T, Loeff FC, de Vries A, Allen MH, Barbosa IA, Baudry D, Dasandi T, Duckworth M, Meynell F, Russell A, Chapman A, McBride S, McKenna K, Perera G, Ramsay H, Ramesh R, Sands K, Shipman A, Burden AD, Griffiths CEM, Reynolds NJ, Warren RB, Mahil S, Barker J, Dand N, Smith C, Simpson MA. Development of antidrug antibodies against adalimumab maps to variation within the HLA-DR peptide-binding groove. JCI Insight, 2023; 8(4).
2022
Krieckaert CLM, van Tubergen A, Gehin JE, Hernández-Breijo B, Le Mélédo G, Balsa A, Böhm P, Cucnik S, Elkayam O, Goll GL, Hooijberg F, Jani M, Kiely PDW, McCarthy N, Mulleman D, Navarro-Compán V, Payne K, Perry ME, Plasencia-Rodriguez C, Stones SR, Syversen SW, de Vries A, Ward KM, Wolbink G, Isaacs JD. EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases. Ann Rheum Dis, 2022.
2020
Berkhout LC, Vogelzang EH, Hart MM, Loeff FC, Dijk L, Derksen NIL, Wieringa R, van Leeuwen WA, Krieckaert CLM, de Vries A, Nurmohamed MT, Wolbink GJ, Rispens T. The effect of certolizumab drug concentration and anti-drug antibodies on TNF neutralisation. Clin Exp Rheumatol, 2020; 38(2):306–313.
2019
Ruwaard J, Marsman AF, Nurmohamed MT, van der Horst-Bruinsma IE, Te Velthuis H, Bloem K, de Vries A, Rispens T, Wolbink G. Antidrug antibody detection for adalimumab depends on the type of assay used: An experimental approach to help clinicians interpret diagnostic data. Clin Exp Rheumatol, 2019; 37(5):756–761.
Berger A-E, Duru G, de Vries A, Marini JC, Aoucheta D, Cornillie F, Nancey S, Detrez I, Gils A, Roblin X, Paul S. Comparison of immunoassays for measuring serum levels of golimumab and antibodies against golimumab in ulcerative colitis: A retrospective observational study. Therapeutic Drug Monitoring, 2019; 41(4):459–466.
2017
Darrouzain F, Bian S, Desvignes C, Bris C, Watier H, Paintaud G, de Vries A. Immunoassays for measuring serum concentrations of monoclonal antibodies and anti-biopharmaceutical antibodies in patients. Therapeutic Drug Monitoring, 2017; 39(4):316–321.
Arno Kromminga, PhD
Arno Kromminga has contributed extensively to the scientific community through peer-reviewed publications, conference presentations, and industry white papers, particularly in the fields of immunogenicity assessment and bioanalytical strategy.
2025
Grudzinska-Goebel J, Kromminga A, Snoeck V, et al. Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: Recommendations from the European Immunogenicity Platform. Front Immunol, 2025; 16:1581153.
Tourdot S, Kromminga A, et al. Proceedings of the 15th European Immunogenicity Platform open symposium on immunogenicity of biopharmaceuticals. MAbs, 2025; 17(1):2487604.
Tovey, MG, Kromminga A, Mytych, DT. Editorial: The immune response to therapeutic antibodies. 2025 Feb 10:16:1554297. doi: 10.3389/fimmu.2025.1554297.
2024
Cowan KJ, Kromminga A, Timmerman P, et al. The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays. Bioanalysis, 2024; 5:1–7.
2022
Lotz GP, Kromminga A, Snoeck V, et al. When to extend monitoring of anti-drug antibodies for high-risk biotherapeutics in clinical trials: An opinion from the European Immunogenicity Platform. AAPS J, 2022; 24(3):68.
2021
Corsaro B, Garofolo F, Kromminga A, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, et al. 2020 White Paper on recent issues in bioanalysis: Vaccine assay validation, qPCR assay validation, QC for CAR-T flow cytometry, NAb assay harmonization and ELISpot validation (Part 3—Recommendations on immunogenicity assay strategies, NAb assays, biosimilars and FDA/EMA immunogenicity guidance/guideline, gene and cell therapy and vaccine assays). Bioanalysis, 2021; 13:415–463.
2020
Gorovits B, Peng K, Kromminga A. Current considerations on characterization of immune response to multi-domain biotherapeutics. BioDrugs, 2020; 34:39–54.
2016
Wadhwa M, Mytych DT, Bird C, Barger T, Dougall T, Han H, Rigsby P, Kromminga A, Thorpe R; Participants of the Study. Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study. J Immunol Methods, 2016; 435:32–42.
Curtin F, Vidal V, Bernard C, Kromminga A, Lang AB, Porchet H. Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study. MAbs, 2016; 8:854–860.
2015
Shankar G, Arkin S, Devanarayan V, Kromminga A, et al. The quintessence of immunogenicity reporting for biotherapeutics. Nat Biotechnol, 2015; 33:334–336.
2014
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides—harmonized terminology and tactical recommendations. AAPS J, 2014; 16:658–673.
2005
Kromminga A, Schellekens H. Antibodies against erythropoietin and other protein-based therapeutics: An overview. Ann N Y Acad Sci, 2005; 1050:257–265.