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Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, Quarmby V, Richards S, Schneider CK, Subramanyam M, Swanson S, Verthelyi D, Yim S; American Association of Pharmaceutical Scientists. Shankar G, et al. Among authors: kromminga a. AAPS J. 2014 Jul;16(4):658-73. doi: 10.1208/s12248-014-9599-2. Epub 2014 Apr 24. AAPS J. 2014. PMID: 24764037 Free PMC article.
The quintessence of immunogenicity reporting for biotherapeutics.
Shankar G, Arkin S, Devanarayan V, Kromminga A, Quarmby V, Richards S, Subramanyam M, Swanson S. Shankar G, et al. Among authors: kromminga a. Nat Biotechnol. 2015 Apr;33(4):334-6. doi: 10.1038/nbt.3181. Nat Biotechnol. 2015. PMID: 25850051 No abstract available.
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 & Cell Therapy and Vaccine Assays).
Corsaro B, Yang TY, Murphy R, Sonderegger I, Exley A, Bertholet S, Dakappagari N, Dessy F, Garofolo F, Kierstead L, Koch H, Sarikonda G, Savoie N, Siggers R, Solstad T, Lu Y, Milton M, Marshall JC, DelCarpini J, Gorovits B, Gupta S, Jesaitis L, Kamerud J, Kromminga A, Ma A, McNally J, Yan H, Wu B, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, Rajadhyaksha M, Staack RF, Cherry E, Cludts I, Dahlbäck M, Gunn GR, Ishii-Watabe A, Jawa V, Kubiak R, Partridge M, Petrillo M, Pine SO, Poetzl J, Song S, Stebbins C, Wu Y, Zhang L, Kar S, Liang M, Abhari MR, Schweighardt B, Stubenrauch K, Xu Y. Corsaro B, et al. Among authors: kromminga a. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
Lotz GP, Benstein K, Bloem K, Buddiger H, Calonder C, Elm S, Fernandez E, Goodman J, Gorovits B, Grudzinska-Goebel J, Janssen M, Jawa V, Kramer D, Luo L, Malisauskas M, Michaut L, Schäfer M, Spindeldreher S, Ullmann M, Nana Weldingh K, Kromminga A, Snoeck V. Lotz GP, et al. Among authors: kromminga a. AAPS J. 2022 May 12;24(3):68. doi: 10.1208/s12248-022-00712-2. AAPS J. 2022. PMID: 35554731
Managing unwanted immunogenicity of biologicals.
Deehan M, Garcês S, Kramer D, Baker MP, Rat D, Roettger Y, Kromminga A. Deehan M, et al. Among authors: kromminga a. Autoimmun Rev. 2015 Jul;14(7):569-74. doi: 10.1016/j.autrev.2015.02.007. Epub 2015 Mar 2. Autoimmun Rev. 2015. PMID: 25742758 Review.
Immunogenicity of rituximab in patients with severe pemphigus.
Schmidt E, Hennig K, Mengede C, Zillikens D, Kromminga A. Schmidt E, et al. Among authors: kromminga a. Clin Immunol. 2009 Sep;132(3):334-41. doi: 10.1016/j.clim.2009.05.007. Epub 2009 Jun 7. Clin Immunol. 2009. PMID: 19502112
73 results