1. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays). (December 2017) Authors: Gupta, Shalini; Richards, Susan; Amaravadi, Lakshmi; Piccoli, Steven; Desilva, Binodh; Pillutla, Renuka; Stevenson, Lauren; Mehta, Devangi; Carrasco-Triguero, Montserrat; Neely, Robert; Partridge, Michael; Staack, Roland F; Zhao, Xuemei; Gorovits, Boris; Kolaitis, Gerry; Sumner, Giane; Stubenrauc... Journal: Bioanalysis Issue: Volume 9:Number 24(2017) Page Start: 1967 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. 2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs). (December 2017) Authors: Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun (Julia); Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Ar... Journal: Bioanalysis Issue: Volume 9:Number 23(2017) Page Start: 1895 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. 2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis). (29th November 2018) Authors: Welink, Jan; Xu, Yuanxin; Yang, Eric; Wilson, Amanda; Henderson, Neil; Luo, Lina; Fraser, Stephanie; Kavita, Uma; Musuku, Adrien; James, Christopher; Fraier, Daniela; Zhang, Yan; Goykhman, Dina; Summerfield, Scott; Woolf, Eric; Verhaeghe, Tom; Hughes, Nicola; Behling, Alexander; Brown, Kirk; Buly... Journal: Bioanalysis Issue: Volume 10:Number 22(2018) Page Start: 1781 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. 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) ↗
5. 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) ↗
6. Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab. (August 2017) Authors: Cludts, Isabelle; Spinelli, Francesca Romana; Morello, Francesca; Hockley, Jason; Valesini, Guido; Wadhwa, Meenu Journal: Cytokine Issue: Volume 96(2017) Page Start: 16 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Reprint of "Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab". (January 2018) Authors: Cludts, Isabelle; Spinelli, Francesca Romana; Morello, Francesca; Hockley, Jason; Valesini, Guido; Wadhwa, Meenu Journal: Cytokine Issue: Volume 101(2018) Page Start: 70 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗