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1.

A Cytometrist's Guide to Coordinating and Performing Effective COVID-19 Research.

Chattopadhyay, Pratip K; Filby, Andrew; Jellison, Evan R; Ferrari, Guido; Green, Cherie; Cherian, Sindhu; Irish, Jonathan; Litwin, Virginia.

Cytometry A ; 99(1): 11-18, 2021 01.

Article in English | MEDLINE | ID: mdl-32881296

2.

Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2019 Conference Workshops.

Czechowska, Kamila; Lannigan, Joanne; Aghaeepour, Nima; Back, Jessica B; Begum, Julfa; Behbehani, Greg; Bispo, Cláudia; Bitoun, Daniel; Fernández, Alfonso Blanco; Boova, Samuel Tony; Brinkman, Ryan Remy; Ciccolella, Christopher O; Cotleur, Bunny; Davies, Derek; Dela Cruz, Gelo Victoriano; Del Rio-Guerra, Roxana; Des Lauriers-Cox, Ann Marie; Douagi, Iyadh; Dumrese, Claudia; Bonilla Escobar, Diana L; Estevam, Jose; Ewald, Christina; Fossum, Anna; Gaudillière, Brice; Green, Cherie; Groves, Christopher; Hall, Christopher; Haque, Yasmin; Hedrick, Michael Nathan; Hogg, Karen; Hsieh, Elena W Y; Irish, Jonathan; Lederer, James; Leipold, Michael; Lewis-Tuffin, Laura J; Litwin, Virginia; Lopez, Peter; Nasdala, Ines; Nedbal, Jakub; Ohlsson-Wilhelm, Betsy M; Price, Kylie M; Rahman, Adeeb H; Rayanki, Radhika; Rieger, Aja M; Robinson, J Paul; Shapiro, Howard; Sun, Yongliang Steve; Tang, Vera A; Tesfa, Lydia; Telford, William G.

Cytometry A ; 95(12): 1236-1274, 2019 12.

Article in English | MEDLINE | ID: mdl-31833655

3.

Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2018 Conference Workshops.

Czechowska, Kamila; Lannigan, Joanne; Wang, Lili; Arcidiacono, Judith; Ashhurst, Thomas M; Barnard, Ruth M; Bauer, Steven; Bispo, Cláudia; Bonilla, Diana L; Brinkman, Ryan R; Cabanski, Maciej; Chang, Hyun-Dong; Chakrabarti, Lina; Chojnowski, Grace; Cotleur, Bunny; Degheidy, Heba; Dela Cruz, Gelo V; Eck, Steven; Elliott, John; Errington, Rachel; Filby, Andy; Gagnon, Dominic; Gardner, Rui; Green, Cherie; Gregory, Michael; Groves, Christopher J; Hall, Christopher; Hammes, Frederik; Hedrick, Michael; Hoffman, Robert; Icha, Jaroslav; Ivaska, Johanna; Jenner, Dominic C; Jones, Derek; Kerckhof, Frederiek-Maarten; Kukat, Christian; Lanham, David; Leavesley, Silas; Lee, Michael; Lin-Gibson, Sheng; Litwin, Virginia; Liu, Yanli; Molloy, Jenny; Moore, Jonni S; Müller, Susann; Nedbal, Jakub; Niesner, Raluca; Nitta, Nao; Ohlsson-Wilhelm, Betsy; Paul, Nicole E.

Cytometry A ; 95(6): 598-644, 2019 06.

Article in English | MEDLINE | ID: mdl-31207046

4.

Flow Cytometry Method Validation Protocols.

Selliah, Nithianandan; Nash, Veronica; Eck, Steven; Green, Cherie; Oldaker, Teri; Stewart, Jennifer; Vitaliti, Alessandra; Litwin, Virginia.

Curr Protoc ; 3(8): e868, 2023 Aug.

Article in English | MEDLINE | ID: mdl-37606503

5.

The Evolution of Single-Cell Analysis and Utility in Drug Development.

Mitra-Kaushik, Shibani; Mehta-Damani, Anita; Stewart, Jennifer J; Green, Cherie; Litwin, Virginia; Gonneau, Christèle.

AAPS J ; 23(5): 98, 2021 08 13.

Article in English | MEDLINE | ID: mdl-34389904

6.

High-sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events.

Sommer, Ulrike; Eck, Steven; Marszalek, Laura; Stewart, Jennifer J; Bradford, Jolene; McCloskey, Thomas W; Green, Cherie; Vitaliti, Alessandra; Oldaker, Teri; Litwin, Virginia.

Cytometry B Clin Cytom ; 100(1): 42-51, 2021 01.

Article in English | MEDLINE | ID: mdl-32940947

7.

Flow cytometric method transfer: Recommendations for best practice.

Cabanski, Maciej; Oldaker, Teri; Stewart, Jennifer J; Selliah, Nithianandan; Eck, Steve; Green, Cherie; Litwin, Virginia; Vitaliti, Alessandra.

Cytometry B Clin Cytom ; 100(1): 52-62, 2021 01.

Article in English | MEDLINE | ID: mdl-33207038

8.

Best practices for optimization and validation of flow cytometry-based receptor occupancy assays.

Hilt, Ed; Sun, Yongliang S; McCloskey, Thomas W; Eck, Steve; McIntosh, Thomas; Grugan, Katharine D; Lanham, David F; Standifer, Nathan; Green, Cherie; Litwin, Virginia; Stewart, Jennifer J.

Cytometry B Clin Cytom ; 100(1): 63-71, 2021 01.

Article in English | MEDLINE | ID: mdl-33259706

9.

Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses.

Sarikonda, Ghanashyam; Mathieu, Mélissa; Natalia, Mahwish; Pahuja, Anil; Xue, Qiong; Pierog, Piotr L; Trampont, Paul C; Decman, Vilma; Reynolds, Susan; Hanafi, Laïla-Aïcha; Sun, Yongliang S; Eck, Steven; Hedrick, Michael N; Stewart, Jennifer J; Tangri, Shabnam; Litwin, Virginia; Dakappagari, Naveen.

Cytometry B Clin Cytom ; 100(1): 79-91, 2021 01.

Article in English | MEDLINE | ID: mdl-33373096

10.

Flow Cytometry Method Validation Protocols.

Selliah, Nithianandan; Eck, Steven; Green, Cherie; Oldaker, Teri; Stewart, Jennifer; Vitaliti, Alessandra; Litwin, Virginia.

Curr Protoc Cytom ; 87(1): e53, 2019 01.

Article in English | MEDLINE | ID: mdl-30418706

11.

Correction: Flow Cytometry Method Validation Protocols.

Selliah, Nithianandan; Nash, Veronica; Eck, Steven; Green, Cherie; Oldaker, Teri; Stewart, Jennifer; Vitaliti, Alessandra; Litwin, Virginia.

Curr Protoc ; 4(1): e988, 2024 Jan.

Article in English | MEDLINE | ID: mdl-38270497

12.

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, Steven; Mehta, Devangi; Vitaliti, Alessandra; Allinson, John; Amur, Shashi; Eck, Steve; Green, Cherie; Hedrick, Michael; Hopper, Shirley; Ji, Allena; Joyce, Alison; Litwin, Virginia; Maher, Kevin; Mathews, Joel; Peng, Kun; Safavi, Afshin; Wang, Yow-Ming; Zhang, Yan; Amaravadi, Lakshmi; Palackal, Nisha; Thankamony, Sai; Beaver, Chris; Bame, Eris; Emrich, Thomas; Grimaldi, Christine; Haulenbeek, Jonathan; Joyce, Alison; Kakkanaiah, Vellalore; Lanham, David; Maher, Kevin; Mayer, Andrew; Trampont, Paul C; Vermet, Laurent; Dakappagari, Naveen; Fleener, Catherine; Garofolo, Fabio; Rogers, Cynthia; Tangri, Shabnam; Xu, Yuanxin; Liang, Meina; Rajadhyaksha, Manoj; Richards, Susan; Schweighardt, Becky; Purushothama, Shobha; Baltrukonis, Daniel; Brumm, Jochen; Cherry, Elana; Delcarpini, Jason; Gleason, Carol; Kirshner, Susan.

Bioanalysis ; 11(24): 2207-2244, 2019 Dec.

Article in English | MEDLINE | ID: mdl-31820675

13.

ICCS/ESCCA consensus guidelines to detect GPI-deficient cells in paroxysmal nocturnal hemoglobinuria (PNH) and related disorders part 4 - assay validation and quality assurance.

Oldaker, Teri; Whitby, Liam; Saber, Maryam; Holden, Jeannine; Wallace, Paul K; Litwin, Virginia.

Cytometry B Clin Cytom ; 94(1): 67-81, 2018 01.

Article in English | MEDLINE | ID: mdl-29251828

14.

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, Lauren; Richards, Susan; Pillutla, Renuka; Torri, Albert; Kamerud, John; Mehta, Devangi; Keller, Stephen; Purushothama, Shobha; Gorovits, Boris; Litwin, Virginia; Stebbins, Christopher; Marini, Joseph; Beaver, Chris; Sperinde, Gizette; Siguenza, Patricia; Staack, Roland F; Qiu, Yongchang; Amaravadi, Lakshmi; Amur, Shashi; Fleener, Catherine Aversa; Baltrukonis, Daniel; Catlett, Ian; Cherry, Elana; Chung, Shan; Cludts, Isabelle; Donato, Lorella Di; Fischer, Saloumeh; Fraser, Stephanie; Garofolo, Fabio; Green, Cherie; Gunn, George; Haidar, Sam; Haulenbeek, Jonathan; Henderson, Neil; Hopper, Shirley; Ishii-Watabe, Akiko; Islam, Rafiq; Janelsins, Brian; Jawa, Vibha; Kakkanaiah, Vellalore; Kamondi, Szilard; Kolaitis, Gerry; Kubiak, Robert J; Kumar, Seema; Kurki, Pekka; Liang, Meina; Liu, Patrick; Maxfield, Kimberly; Myler, Heather; Palackal, Nisha.

Bioanalysis ; 10(24): 1973-2001, 2018 Dec.

Article in English | MEDLINE | ID: mdl-30488726

15.

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.

der Strate, Barry van; Longdin, Robin; Geerlings, Marie; Bachmayer, Nora; Cavallin, Maria; Litwin, Virginia; Patel, Minesh; Passe-Coutrin, Wilfried; Schoelch, Corinna; Companjen, Arjen; Fjording, Marianne Scheel.

Bioanalysis ; 9(16): 1253-1264, 2017 Aug.

Article in English | MEDLINE | ID: mdl-28766359

16.

Issue Highlights-November 2021.

Litwin, Virginia.

Cytometry B Clin Cytom ; 100(6): 619-621, 2021 11.

Article in English | MEDLINE | ID: mdl-34787373

17.

Progress towards global standardization for quantitative flow cytometry.

Gonneau, Christèle; Wang, Lili; Mitra-Kaushik, Shibani; Trampont, Paul C; Litwin, Virginia.

Bioanalysis ; 13(21): 1591-1595, 2021 Nov.

Article in English | MEDLINE | ID: mdl-34528829

18.

Saturation monitoring of VX15/2503, a novel semaphorin 4D-specific antibody, in clinical trials.

Fisher, Terrence L; Seils, Jennifer; Reilly, Christine; Litwin, Virginia; Green, Lisa; Salkowitz-Bokal, Janelle; Walsh, Robin; Harville, Sarah; Leonard, John E; Smith, Ernest; Zauderer, Maurice.

Cytometry B Clin Cytom ; 90(2): 199-208, 2016 Mar.

Article in English | MEDLINE | ID: mdl-26566052

19.

Recommendations for the development and validation of flow cytometry-based receptor occupancy assays.

Green, Cherie L; Stewart, Jennifer J; Högerkorp, Carl-Magnus; Lackey, Alan; Jones, Nicholas; Liang, Meina; Xu, Yuanxin; Ferbas, John; Moulard, Maxime; Czechowska, Kamila; Mc Closkey, Thomas W; van der Strate, Barry W A; Wilkins, Danice E C; Lanham, David; Wyant, Timothy; Litwin, Virginia.

Cytometry B Clin Cytom ; 90(2): 141-9, 2016 Mar.

Article in English | MEDLINE | ID: mdl-26566147

20.

Role of receptor occupancy assays by flow cytometry in drug development.

Stewart, Jennifer J; Green, Cherie L; Jones, Nicholas; Liang, Meina; Xu, Yuanxin; Wilkins, Danice E C; Moulard, Maxime; Czechowska, Kamila; Lanham, David; McCloskey, Thomas W; Ferbas, John; van der Strate, Barry W A; Högerkorp, Carl-Magnus; Wyant, Timothy; Lackey, Alan; Litwin, Virginia.

Cytometry B Clin Cytom ; 90(2): 110-6, 2016 Mar.

Article in English | MEDLINE | ID: mdl-26704557

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A Cytometrist's Guide to Coordinating and Performing Effective COVID-19 Research.

Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2019 Conference Workshops.

Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2018 Conference Workshops.

Flow Cytometry Method Validation Protocols.

The Evolution of Single-Cell Analysis and Utility in Drug Development.

High-sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events.

Flow cytometric method transfer: Recommendations for best practice.

Best practices for optimization and validation of flow cytometry-based receptor occupancy assays.

Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses.

Flow Cytometry Method Validation Protocols.

Correction: Flow Cytometry Method Validation Protocols.

ICCS/ESCCA consensus guidelines to detect GPI-deficient cells in paroxysmal nocturnal hemoglobinuria (PNH) and related disorders part 4 - assay validation and quality assurance.

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).

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.

Issue Highlights-November 2021.

Progress towards global standardization for quantitative flow cytometry.

Saturation monitoring of VX15/2503, a novel semaphorin 4D-specific antibody, in clinical trials.

Recommendations for the development and validation of flow cytometry-based receptor occupancy assays.

Role of receptor occupancy assays by flow cytometry in drug development.