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For: 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. 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). Bioanalysis 2021;13:415-63. [PMID: 33533276 DOI: 10.4155/bio-2021-0007] [Cited by in Crossref: 1] [Cited by in F6Publishing: 10] [Article Influence: 1.0] [Reference Citation Analysis]
Number Citing Articles
1 Waerlop G, Leroux-roels G, Lambe T, Bellamy D, Medaglini D, Pettini E, Cox RJ, Trieu M, Davies R, Bredholt G, Montomoli E, Gianchecchi E, Clement F. Harmonization and qualification of an IFN-γ Enzyme-Linked ImmunoSpot assay (ELISPOT) to measure influenza-specific cell-mediated immunity within the FLUCOP consortium. Front Immunol 2022;13:984642. [DOI: 10.3389/fimmu.2022.984642] [Reference Citation Analysis]
2 Wissel M, Poirier M, Satterwhite C, Lin J, Islam R, Zimmer J, Khadang A, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Guilbaud R, Groeber E, Renfrew H, Colletti K, Yu M, Lin J, Fang X, Shah S, Garofolo W, Kar S, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Vance J, Farley E, Matys K, Tabler E, Mylott W, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Shi J, Yamashita J. Recommendations on qPCR/ddPCR Assay Validation by GCC. Bioanalysis 2022. [PMID: 35703321 DOI: 10.4155/bio-2022-0109] [Reference Citation Analysis]
3 Khodayari S, Khodayari H, Ebrahimi-barough S, Khanmohammadi M, Islam MS, Vesovic M, Goodarzi A, Mahmoodzadeh H, Nayernia K, Aghdami N, Ai J. Stem Cell Therapy in Limb Ischemia: State-of-Art, Perspective, and Possible Impacts of Endometrial-Derived Stem Cells. Front Cell Dev Biol 2022;10:834754. [DOI: 10.3389/fcell.2022.834754] [Reference Citation Analysis]
4 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. 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). Bioanalysis 2022;14:505-80. [PMID: 35578993 DOI: 10.4155/bio-2022-0078] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
5 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. 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). Bioanalysis 2022. [PMID: 35578991 DOI: 10.4155/bio-2022-0081] [Reference Citation Analysis]
6 Hersey S, Keller S, Mathews J, King L, Bandukwala A, Berisha F, Birchler M, Bower J, Clausen V, Duarte J, Garofolo F, Hopper S, Kar S, Mabrouk O, Marshall JC, McGuire K, Naughton M, Saito Y, Schuhmann I, Sperinde G, Teixeira P, Vitaliti A, Wang YM, Wnek R, Zhang Y, Spitz S, Decman V, Eck S, Estevam J, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Junker F, Nuti S, Sommer U, Standifer N, Stevens C, Stevens E, Hendricks C, Wadhwa M, Torri A, Ma M, Harris S, Kumar S, Partridge MA, Caiazzo T, Chilewski S, Cludts I, Coble K, Gorovits B, Grimaldi C, Jordan G, Kamerud J, Leary B, Liang M, Lim H, Mayer A, O'Connor E, Palackal N, Poetzl J, Prior S, Abhari MR, Savoie N, Soo C, Ware M, Wu B, Xu Y, Yang TY, Zoghbi J. 2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation). Bioanalysis 2022. [PMID: 35578974 DOI: 10.4155/bio-2022-0080] [Reference Citation Analysis]
7 Islam R, Vance J, Poirier M, Zimmer J, Khadang A, Williams D, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Sheldon C, Guilbaud R, Satterwhite C, Colletti K, Groeber E, Renfrew H, Yu M, Lin J, Fang X, Wissel M, Beadnell T, Lin J, Shah S, Garofolo W, Savoie N, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Farley E, Kierstead L, Mylott W, Tabler E, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Dong K, Shi J, Yamashita J. Recommendations on ELISpot assay validation by the GCC. Bioanalysis 2022;14:187-93. [PMID: 35135309 DOI: 10.4155/bio-2022-0010] [Cited by in F6Publishing: 1] [Reference Citation Analysis]
8 Chen N, Sun K, Chemuturi NV, Cho H, Xia CQ. The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution. AAPS J 2022;24:31. [PMID: 35102450 DOI: 10.1208/s12248-021-00678-7] [Reference Citation Analysis]
9 Nadarajah S. Welcome to volume 14 of Bioanalysis. Bioanalysis 2022;14:1-5. [PMID: 34839717 DOI: 10.4155/bio-2021-0248] [Reference Citation Analysis]
10 Amaravadi L, Palackal N, Garofolo F. Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry. Bioanalysis 2021;13:737-40. [PMID: 34037426 DOI: 10.4155/bio-2021-0086] [Cited by in F6Publishing: 2] [Reference Citation Analysis]