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Page 1
Qualification and application of a surface plasmon resonance-based assay for monitoring potential HAHA responses induced after passive administration of a humanized anti Lewis-Y antibody.
Szolar OH, Stranner S, Zinoecker I, Mudde GC, Himmler G, Waxenecker G, Nechansky A. Szolar OH, et al. Among authors: waxenecker g. J Pharm Biomed Anal. 2006 Jun 16;41(4):1347-53. doi: 10.1016/j.jpba.2006.03.026. Epub 2006 Apr 27. J Pharm Biomed Anal. 2006. PMID: 16644171
Heterogeneous alterations in human alloimmunity associated with immunization.
Roddy M, Clemente M, Poggio ED, Bukowski R, Thakkar S, Waxenecker G, Loibner H, Himmler G, Hricik DE, Heeger PS. Roddy M, et al. Among authors: waxenecker g. Transplantation. 2005 Aug 15;80(3):297-302. doi: 10.1097/01.tp.0000168148.56669.61. Transplantation. 2005. PMID: 16082322 Clinical Trial.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Kaur S, Alley SC, Szapacs M, Wilson A, Ciccimaro E, Su D, Henderson N, Chen L, Garofolo F, Hengel S, Jian W, Kellie JF, Lee A, Mehl J, Palandra J, Qiu H, Savoie N, Shakleya D, Staelens L, Sugimoto H, Sumner G, Welink J, Wheller R, Xue YJ, Zeng J, Zhang J, Zhou H, Wang J, Summerfield S, Kavetska O, Dillen L, Ramanathan R, Baratta M, Dasgupta A, Edmison A, Ferrari L, Fischer S, Fraier D, Haidar S, Heermeier K, James C, Ji A, Luo L, Lima Santos GM, Post N, Rosenbaum AI, Sporring S, Surapaneni S, Vinter S, Wan K, Woolf E, Kavetska O, Cho SJ, Kossary E, Prior S, Abhari MR, Soo C, Wang YM, Bandukwala A, Cherry E, Cludts I, Ghosh S, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Maxfield K, Pedras-Vasconcelos J, Saito Y, Smith D, Solstad T, Verthelyi D, Wadhwa M, Wagner L, Waxenecker G, Yan H, Zhang L. Kaur S, et al. Among authors: waxenecker g. Bioanalysis. 2022 May;14(9):505-580. doi: 10.4155/bio-2022-0078. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578993
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, McGuire K, Nolan K, Pan L, Potthoff B, Purushothama S, Smith D, Solstad T, Sonderegger I, Taddeo F, Tangri S, Wagner L, Wu B, Xu Y, Kirshner S, Verthelyi D, Yan H, Maxfield K, Pedras-Vasconcelos J, Abhari MR, Gupta S, Wu Y, Rajadhyaksha M, Andisik M, Baltrukonis D, Cherry E, Cludts I, Gunn G, Millner AH, Jordan G, Kar S, Kubiak R, Lotz GP, Palmer R, Peng K, Poetzl J, Richards S, Savoie N, Staack RF, Stubenrauch K, Wadhwa M, Waxenecker G, Yang TY, Zhang L. Loo L, et al. Among authors: waxenecker g. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991
Predicting the safety of medicines in pregnancy: A workshop report.
Clements JM, Hawkes RG, Jones D, Adjei A, Chambers T, Simon L, Stemplewski H, Berry N, Price S, Pirmohamed M, Piersma AH, Waxenecker G, Barrow P, Beekhuijzen MEW, Fowkes A, Prior H, Sewell F. Clements JM, et al. Among authors: waxenecker g. Reprod Toxicol. 2020 Apr;93:199-210. doi: 10.1016/j.reprotox.2020.02.011. Epub 2020 Feb 29. Reprod Toxicol. 2020. PMID: 32126282 Free article.
In support of the European Union biosimilar framework.
Schneider CK, Borg JJ, Ehmann F, Ekman N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). Schneider CK, et al. Among authors: waxenecker g. Nat Biotechnol. 2012 Aug;30(8):745-8; author reply 748-9. doi: 10.1038/nbt.2322. Nat Biotechnol. 2012. PMID: 22871707 No abstract available.