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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. Spitz S, et al. Among authors: mccausland m. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867 Free article.
Adjuvanted H5N1 influenza vaccine enhances both cross-reactive memory B cell and strain-specific naive B cell responses in humans.
Ellebedy AH, Nachbagauer R, Jackson KJL, Dai YN, Han J, Alsoussi WB, Davis CW, Stadlbauer D, Rouphael N, Chromikova V, McCausland M, Chang CY, Cortese M, Bower M, Chennareddy C, Schmitz AJ, Zarnitsyna VI, Lai L, Rajabhathor A, Kazemian C, Antia R, Mulligan MJ, Ward AB, Fremont DH, Boyd SD, Pulendran B, Krammer F, Ahmed R. Ellebedy AH, et al. Among authors: mccausland m. Proc Natl Acad Sci U S A. 2020 Jul 28;117(30):17957-17964. doi: 10.1073/pnas.1906613117. Epub 2020 Jul 13. Proc Natl Acad Sci U S A. 2020. PMID: 32661157 Free PMC article.
Breadth and Functionality of Varicella-Zoster Virus Glycoprotein-Specific Antibodies Identified after Zostavax Vaccination in Humans.
Sullivan NL, Reuter-Monslow MA, Sei J, Durr E, Davis CW, Chang C, McCausland M, Wieland A, Krah D, Rouphael N, Mehta AK, Mulligan MJ, Pulendran B, Ahmed R, Vora KA. Sullivan NL, et al. Among authors: mccausland m. J Virol. 2018 Jun 29;92(14):e00269-18. doi: 10.1128/JVI.00269-18. Print 2018 Jul 15. J Virol. 2018. PMID: 29743372 Free PMC article.
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