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Year Number of Results
2001 4
2002 1
2003 1
2004 2
2005 1
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2007 2
2009 4
2010 5
2012 1
2014 2
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2016 2
2017 2
2018 4
2019 2
2020 1
2021 3
2022 1
2024 0

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Page 1
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: schweighardt b. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276 Free article.
PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development.
Ivens IA, Achanzar W, Baumann A, Brändli-Baiocco A, Cavagnaro J, Dempster M, Depelchin BO, Rovira AR, Dill-Morton L, Lane JH, Reipert BM, Salcedo T, Schweighardt B, Tsuruda LS, Turecek PL, Sims J. Ivens IA, et al. Among authors: schweighardt b. Toxicol Pathol. 2015 Oct;43(7):959-83. doi: 10.1177/0192623315591171. Epub 2015 Aug 3. Toxicol Pathol. 2015. PMID: 26239651 Review.
ELISPOT cell rescue.
Meiklejohn DA, Karlsson RK, Karlsson AC, Chapman JM, Nixon DF, Schweighardt B. Meiklejohn DA, et al. Among authors: schweighardt b. J Immunol Methods. 2004 May;288(1-2):135-47. doi: 10.1016/j.jim.2004.03.006. J Immunol Methods. 2004. PMID: 15183092
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Among authors: schweighardt b. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Free article. Review.
Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria.
Qi Y, Patel G, Henshaw J, Gupta S, Olbertz J, Larimore K, Harding CO, Merilainen M, Zori R, Longo N, Burton BK, Li M, Gu Z, Zoog SJ, Weng HH, Schweighardt B. Qi Y, et al. Among authors: schweighardt b. Clin Transl Sci. 2021 Sep;14(5):1894-1905. doi: 10.1111/cts.13043. Epub 2021 May 31. Clin Transl Sci. 2021. PMID: 34057292 Free PMC article. Clinical Trial.
36 results