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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, Hughes N, Kar S, Kellie J, Kim YJ, Lassman M, Mehl J, Morgan L, Palandra J, Sarvaiya H, Zeng J, Zheng N, Wang J, Yuan L, Ji A, Kochansky C, Tao L, Huang Y, Maes E, Barbero L, Contrepois K, Ferrari L, Fu Y, Johnson J, Jones B, Kansal M, Lu Y, Post N, Shen HH, Xue YY, Zhang YC, Biswas G, Cho SJ, Edmison A, Benson K, Abberley L, Azadeh M, Francis J, Garofolo F, Gupta S, Ivanova ID, Ishii-Watabe A, Karnik S, Kassim S, Kavetska O, Keller S, Kossary E, Li W, McCush F, Mendes DN, Abhari MR, Scheibner K, Sikorski T, Staack RF, Tabler E, Tang H, Wan K, Wang YM, Whale E, Yang L, Zimmer J, Bandukwala A, Du X, Kholmanskikh O, Gijsel SK, Wadhwa M, Xu J, Buoninfante A, Cludts I, Diebold S, Maxfield K, Mayer C, Pedras-Vasconcelos J, Abhari MR, Shubow S, Tanaka Y, Tounekti O, Verthelyi D, Wagner L. Baratta M, et al. Among authors: mendes dn. Bioanalysis. 2024;16(9):307-364. doi: 10.1080/17576180.2024.2347153. Epub 2024 May 27. Bioanalysis. 2024. PMID: 38913185
Harmonization of Vaccine Ligand Binding Assays Validation.
Dessy F, Sonderegger I, Wagner L, Buoninfante A, Wadhwa M, Agnes J, Aksyuk A, Baclin A, Bonhomme M, Cloney-Clark S, Corsaro B, Neto JT, Fries L, Gagnon L, Garofolo F, Giardina P, Green T, Guimera N, Harris S, Helmy R, Huleatt J, Ishii-Watabe A, Jaeger R, Jani D, Janssen S, Kierstead L, Makar K, Marshall JC, Mayer C, Mendes DN, Murphy R, Nadarajah S, Nolan K, Plested J, Scully I, Solstad T, Stoop J, Tan C, Verch T, Wilkins D, Xu A, Zheng L, Zhu M. Dessy F, et al. Among authors: mendes dn. Bioanalysis. 2024;16(19-20):1067-1091. doi: 10.1080/17576180.2024.2411925. Epub 2024 Nov 14. Bioanalysis. 2024. PMID: 39540375