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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. Piccoli S, et al. Among authors: corsaro b. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675 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. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276 Free article.
Safety and immunogenicity of fully liquid and lyophilized formulations of an investigational trivalent group B streptococcus vaccine in healthy non-pregnant women: Results from a randomized comparative phase II trial.
Beran J, Leroux-Roels G, Van Damme P, de Hoon J, Vandermeulen C, Al-Ibrahim M, Johnson C, Peterson J, Baker S, Seidl C, Dreisbach A, Karsten A, Corsaro B, Henry O, Lattanzi M, Bebia Z. Beran J, et al. Among authors: corsaro b. Vaccine. 2020 Apr 3;38(16):3227-3234. doi: 10.1016/j.vaccine.2020.02.085. Epub 2020 Mar 10. Vaccine. 2020. PMID: 32169390 Free article. Clinical Trial.
Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4-6 Years After a First Dose: Results From a Phase 2 Trial.
Leroux-Roels G, Bebia Z, Maes C, Aerssens A, De Boever F, Grassano L, Buffi G, Margarit I, Karsten A, Cho S, Slobod K, Corsaro B, Henry O. Leroux-Roels G, et al. Among authors: corsaro b. Clin Infect Dis. 2020 Jun 10;70(12):2570-2579. doi: 10.1093/cid/ciz737. Clin Infect Dis. 2020. PMID: 31394574 Free PMC article. Clinical Trial.
Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine.
Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinón-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, Innis BL; Flu4VEC Study Group. Danier J, et al. Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387. Pediatr Infect Dis J. 2019. PMID: 31306399 Clinical Trial.
Serocorrelates of protection against infant group B streptococcus disease.
Le Doare K, Kampmann B, Vekemans J, Heath PT, Goldblatt D, Nahm MH, Baker C, Edwards MS, Kwatra G, Andrews N, Madhi SA, Ter Meulen AS, Anderson AS, Corsaro B, Fischer P, Gorringe A. Le Doare K, et al. Among authors: corsaro b. Lancet Infect Dis. 2019 May;19(5):e162-e171. doi: 10.1016/S1473-3099(18)30659-5. Epub 2019 Jan 22. Lancet Infect Dis. 2019. PMID: 30683467 Review.
Prevention of vaccine-matched and mismatched influenza in children aged 6-35 months: a multinational randomised trial across five influenza seasons.
Claeys C, Zaman K, Dbaibo G, Li P, Izu A, Kosalaraksa P, Rivera L, Acosta B, Arroba Basanta ML, Aziz A, Cabanero MA, Chandrashekaran V, Corsaro B, Cousin L, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Friel D, Garcia-Sicilia J, Gomez-Go GD, Antoinette Gonzales ML, Hughes SM, Jackowska T, Kant S, Lucero M, Malvaux L, Mares Bermudez J, Martinon-Torres F, Miranda M, Montellano M, Peix Sambola MA, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Salamanca de la Cueva I, Sokal E, Soni J, Szymanski H, Ulied A, Schuind A, Jain VK, Innis BL; Flu4VEC Study Group. Claeys C, et al. Among authors: corsaro b. Lancet Child Adolesc Health. 2018 May;2(5):338-349. doi: 10.1016/S2352-4642(18)30062-2. Epub 2018 Mar 5. Lancet Child Adolesc Health. 2018. PMID: 30169267 Clinical Trial.
Immunogenicity and safety of measles-mumps-rubella, varicella and Haemophilus influenzae type b vaccines administered concurrently with a fourth dose of heptavalent pneumococcal conjugate vaccine compared with the vaccines administered without heptavalent pneumococcal conjugate vaccine.
Black SB, Cimino CO, Hansen J, Lewis E, Ray P, Corsaro B, Graepel J, Laufer D. Black SB, et al. Among authors: corsaro b. Pediatr Infect Dis J. 2006 Apr;25(4):306-11. doi: 10.1097/01.inf.0000207409.92198.6f. Pediatr Infect Dis J. 2006. PMID: 16567981 Clinical Trial.
Relationship between serum bactericidal activity and serogroup-specific immunoglobulin G concentration for adults, toddlers, and infants immunized with Neisseria meningitidis serogroup C vaccines.
Sikkema DJ, Friedman KE, Corsaro B, Kimura A, Hildreth SW, Madore DV, Quataert SA. Sikkema DJ, et al. Among authors: corsaro b. Clin Diagn Lab Immunol. 2000 Sep;7(5):764-8. doi: 10.1128/CDLI.7.5.764-768.2000. Clin Diagn Lab Immunol. 2000. PMID: 10973451 Free PMC article. Clinical Trial.
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