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. Assay format diversity in pre-clinical immunogenicity risk assessment: Toward a possible harmonization of antigenicity assays. Issue 1 (1st January 2022) Authors: Ducret, Axel; Ackaert, Chloé; Bessa, Juliana; Bunce, Campbell; Hickling, Timothy; Jawa, Vibha; Kroenke, Mark A.; Lamberth, Kasper; Manin, Anaïs; Penny, Hweixian L.; Smith, Noel; Terszowski, Grzegorz; Tourdot, Sophie; Spindeldreher, Sebastian Journal: MAbs Issue: Volume 14:Issue 1(2022) Page Start: Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response. (December 2017) Authors: Starcevic Manning, Marta; Kroenke, Mark A; Lee, Stephanie A; Harrison, Simon E; Hoofring, Sarah A; Mytych, Daniel T; Jawa, Vibha Journal: Bioanalysis Issue: Volume 9:Number 23(2017) Page Start: 1849 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry. (20th April 2020) Authors: Mytych, Daniel T.; Park, Joseph K.; Kim, June; Barger, Troy E.; Boshier, Andy; Jawa, Vibha; Kuter, David J. Journal: British journal of haematology Issue: Volume 190:Number 6(2020) Page Start: 923 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Development of a Human Antibody Tolerant Mouse Model to Assess the Immunogenicity Risk Due to Aggregated Biotherapeutics. Issue 10 (7th August 2013) Authors: Bi, Vivian; Jawa, Vibha; Joubert, Marisa K.; Kaliyaperumal, Arunan; Eakin, Catherine; Richmond, Karen; Pan, Oscar; Sun, Jilin; Hokom, Martha; Goletz, Theresa J.; Wypych, Jette; Zhou, Lei; Kerwin, Bruce A.; Narhi, Linda O.; Arora, Taruna Journal: Journal of pharmaceutical sciences Issue: Volume 102:Issue 10(2013:Oct.) Page Start: 3545 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Holistic analytical characterization and risk assessment of residual host cell protein impurities in an active pharmaceutical ingredient synthesized by biocatalysts. Issue 8 (4th May 2022) Authors: Wang, Fengqiang; Li, Xuanwen; Swanson, Michael; Guetschow, Erik; Winston, Matthew; Smith, Joseph P.; Hoyt, Erik; Liu, Zhijian; Richardson, Douglas; Bu, Xiaodong; Jawa, Vibha; Variankaval, Narayan Journal: Biotechnology and bioengineering Issue: Volume 119:Issue 8(2022) Page Start: 2088 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Identification and characterization of a residual host cell protein hexosaminidase B associated with N‐glycan degradation during the stability study of a therapeutic recombinant monoclonal antibody product. (12th March 2021) Authors: Li, Xuanwen; An, Yan; Liao, Jing; Xiao, Li; Swanson, Michael; Martinez‐Fonts, Kirby; Pavon, Jorge Alexander; Sherer, Edward C.; Jawa, Vibha; Wang, Fengqiang; Gao, Xinliu; Letarte, Simon; Richardson, Douglas D. Journal: Biotechnology progress Issue: Volume 37:Number 3(2021) Page Start: n/a Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis. (January 2014) Authors: Wang, Yow-Ming C; Jawa, Vibha; Ma, Mark Journal: Bioanalysis Issue: Volume 6:Number 1(2014) Page Start: 79 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Physical Characterization and In Vitro Biological Impact of Highly Aggregated Antibodies Separated into Size‐Enriched Populations by Fluorescence‐Activated Cell Sorting. Issue 5 (5th March 2015) Authors: Telikepalli, Srivalli; Shinogle, Heather E.; Thapa, Prem S.; Kim, Jae Hyun; Deshpande, Meghana; Jawa, Vibha; Middaugh, C. Russell; Narhi, Linda O.; Joubert, Marisa K.; Volkin, David B. Journal: Journal of pharmaceutical sciences Issue: Volume 104:Issue 5(2015:May) Page Start: 1575 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. Unexpected Thrombocytopenia and Anemia in Cynomolgus Monkeys Induced by a Therapeutic Human Monoclonal Antibody. (October 2013) Authors: Everds, Nancy; Li, Nianyu; Bailey, Keith; Fort, Madeline; Stevenson, Riki; Jawando, Remi; Salyers, Kevin; Jawa, Vibha; Narayanan, Padma; Stevens, Erin; He, Ching; Nguyen, Mai Phuong; Tran, Sam; Doyle, Nancy; Poitout-Belissent, Florence; Jolette, Jacquelin; Xu, Cen; Sprugel, Katherine Journal: Toxicologic pathology Issue: Volume 41:Number 7(2013) Page Start: 951 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗