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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: stebbins c. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Free article. Review.
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A. Koren E, et al. Among authors: stebbins cc. J Immunol Methods. 2008 Apr 20;333(1-2):1-9. doi: 10.1016/j.jim.2008.01.001. Epub 2008 Jan 29. J Immunol Methods. 2008. PMID: 18275969 Review.
Serum IL-17F does not predict poor response to IM IFNβ-1a in relapsing-remitting MS.
Bushnell SE, Zhao Z, Stebbins CC, Cadavid D, Buko AM, Whalley ET, Davis JA, Versage EM, Richert JR, Axtell RC, Steinman L, Medori R. Bushnell SE, et al. Among authors: stebbins cc. Neurology. 2012 Aug 7;79(6):531-7. doi: 10.1212/WNL.0b013e318259e123. Epub 2012 May 9. Neurology. 2012. PMID: 22573631 Free PMC article.
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Welink J, Xu Y, Yang E, Wilson A, Henderson N, Luo L, Fraser S, Kavita U, Musuku A, James C, Fraier D, Zhang Y, Goykhman D, Summerfield S, Woolf E, Verhaeghe T, Hughes N, Behling A, Brown K, Bulychev A, Buonarati M, Cherry E, Cho SJ, Cludts I, Dillen L, Dodge R, Edmison A, Garofolo F, Green R, Haidar S, Hottenstein C, Ishii-Watabe A, Jang HG, Ji A, Jones B, Kassim S, Ma M, Lima Santos GM, Norris DA, Owen T, Piccoli S, Ramanathan R, Röhl I, Rosenbaum AI, Saito Y, Sangster T, Savoie N, Stebbins C, Sydor J, de Merbel NV, Verthelyi D, Vinter S, Whale E. Welink J, et al. Among authors: stebbins c. Bioanalysis. 2018 Nov 1;10(22):1781-1801. doi: 10.4155/bio-2018-0268. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488725 Free article.
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: stebbins c. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276 Free article.
Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs.
Henry SP, Arfvidsson C, Arrington J, Canadi J, Crowe D, Gupta S, Lohmann S, Massonnet B, Mytych D, Rogers T, Rogers H, Stebbins C, Stovold C, Verthelyi D, Vigil A, Xuan C, Xu Y, Yu R, Klem T. Henry SP, et al. Among authors: stebbins c. Nucleic Acid Ther. 2022 Oct;32(5):369-377. doi: 10.1089/nat.2021.0112. Epub 2022 Sep 29. Nucleic Acid Ther. 2022. PMID: 36178478
173 results