1. 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). (29th November 2018) Authors: 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, Yongcha... Journal: Bioanalysis Issue: Volume 10:Number 24(2018) Page Start: 1973 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. 2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity). (29th November 2018) Authors: Neubert, Hendrik; Olah, Timothy; Lee, Anita; Fraser, Stephanie; Dodge, Robert; Laterza, Omar; Szapacs, Matthew; Alley, Stephen C; Saad, Ola M; Amur, Shashi; Chen, Linzhi; Cherry, Elana; Cho, Seongeun (Julia); Cludts, Isabelle; Donato, Lorella Di; Edmison, Anna; Ferrari, Luca; Garofolo, Fabio; Hai... Journal: Bioanalysis Issue: Volume 10:Number 23(2018) Page Start: 1897 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Bioanalytical considerations in the comparability assessment of biotherapeutics. (March 2011) Authors: Lee, Jean W; Wang, Yow-Ming; Moxness, Michael; DeSilva, Binodh Journal: Bioanalysis Issue: Volume 3:Number 6(2011) Page Start: 613 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Bioanalytical considerations in the comparability assessment of biotherapeutics. (March 2011) Authors: Lee, Jean W; Wang, Yow-Ming; Moxness, Michael; DeSilva, Binodh Journal: Bioanalysis Issue: Volume 3:Number 6(2011) Page Start: 613 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗