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Page 1
Pre-existing Antibody: Biotherapeutic Modality-Based Review.
Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L. Gorovits B, et al. Among authors: liang m. AAPS J. 2016 Mar;18(2):311-20. doi: 10.1208/s12248-016-9878-1. Epub 2016 Jan 28. AAPS J. 2016. PMID: 26821802 Free PMC article. Review.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Among authors: liang m. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Review.
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: liang m. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675
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: liang m. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
Anti-drug Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, Gleason C, Goodman J, Manning MS, Purushothama S, Richards S, Shen H, Zoghbi J, Amaravadi L, Barger T, Bowen S, Bowsher RR, Clements-Egan A, Geng D, Goletz TJ, Gunn GR, Hallett W, Hodsdon ME, Janelsins BM, Jawa V, Kamondi S, Kirshner S, Kramer D, Liang M, Lindley K, Liu S, Liu Z, McNally J, Mikulskis A, Nelson R, Ahbari MR, Qu Q, Ruppel J, Snoeck V, Song A, Yan H, Ware M. Myler H, et al. Among authors: liang m. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.
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: liang m. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
Protein engineering and preclinical development of a GM-CSF receptor antibody for the treatment of rheumatoid arthritis.
Minter RR, Cohen ES, Wang B, Liang M, Vainshtein I, Rees G, Eghobamien L, Harrison P, Sims DA, Matthews C, Wilkinson T, Monk P, Drinkwater C, Fabri L, Nash A, McCourt M, Jermutus L, Roskos L, Anderson IK, Sleeman MA. Minter RR, et al. Among authors: liang m. Br J Pharmacol. 2013 Jan;168(1):200-11. doi: 10.1111/j.1476-5381.2012.02173.x. Br J Pharmacol. 2013. PMID: 22913645 Free PMC article.
5,336 results