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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: kar s. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Islam R, Kar S, Ritzén H, Hays A, Tayyem R, Barry C, Keyhani A, Zimmer J, Cruz Caturla M, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Hughes N, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Cape S, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Garofolo W, Savoie N, Brown M, Rhyne P, Hristopoulos G, Xu A, Goodwin L, Spriggs F, Xu A, Awaiye K, Hayes R, St Charles J, Bouhajib M, DiMarco C, DiMarco L, Savu SR, Bennett P, Kakkanaiah V, Nehls C, Stouffer B, Tabler E, Briscoe C, Karnik S, DuBey I, Kulagina N, Lindsay J, Beaver C, Williard C, Wang H, Feng H, Malone M, Wells E, Fang X, Moussallie M. Islam R, et al. Among authors: kar s. Bioanalysis. 2019 Apr;11(7):645-653. doi: 10.4155/bio-2019-0072. Epub 2019 Apr 17. Bioanalysis. 2019. PMID: 30993999
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: kar s. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867
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: kar s. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bower J, Zimmer J, McCown S, Tabler E, Karnik S, Kar S, Sales K, Vance J, Barry C, Keyhani A, Williams D, Lester T, Garofolo F, Satterwhite C, Groeber E, Renfrew H, Lin J, Cape S, O'Dell M, Fang X, Brant A, Garofolo W, Savoie N, Hayes R, Simchik S, Sun R, Bravo O, Dufield D, Luna M, Xu A, Kane C, Farley E, Sanghvi M, Hays A, Lowes S, Islam R, Hoffpauir B, Beaver C, Dong K, Desai-Krieger D. Bower J, et al. Among authors: kar s. Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13. Bioanalysis. 2021. PMID: 33847160
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).
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. Hersey S, et al. Among authors: kar s. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
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).
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. Loo L, et al. Among authors: kar s. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991
Recommendations on qPCR/ddPCR assay validation by GCC.
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. Wissel M, et al. Among authors: kar s. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, Zhou L. Pan L, et al. Among authors: kar s. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. Szapacs M, et al. Among authors: kar s. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500
2,609 results