233 related articles for article (PubMed ID: 29110222)
1. Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development.
Xue L; Clements-Egan A; Amaravadi L; Birchler M; Gorovits B; Liang M; Myler H; Purushothama S; Manning MS; Sung C
AAPS J; 2017 Nov; 19(6):1576-1586. PubMed ID: 29110222
[TBL] [Abstract][Full Text] [Related]
2. 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
AAPS J; 2016 Mar; 18(2):311-20. PubMed ID: 26821802
[TBL] [Abstract][Full Text] [Related]
3. Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint.
Kumar SC; DelCarpini JA; Qu Q; Kane M; Gorovits B
AAPS J; 2017 Jan; 19(1):313-319. PubMed ID: 27873117
[TBL] [Abstract][Full Text] [Related]
4. Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics.
Gorovits B; Wakshull E; Pillutla R; Xu Y; Manning MS; Goyal J
J Immunol Methods; 2014 Jun; 408():1-12. PubMed ID: 24861938
[TBL] [Abstract][Full Text] [Related]
5. Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.
Tatarewicz SM; Mytych DT; Manning MS; Swanson SJ; Moxness MS; Chirmule N
Bioanalysis; 2014 Jun; 6(11):1509-23. PubMed ID: 25046051
[TBL] [Abstract][Full Text] [Related]
6. Pre-existing biotherapeutic-reactive antibodies: survey results within the American Association of Pharmaceutical Scientists.
Xue L; Fiscella M; Rajadhyaksha M; Goyal J; Holland C; Gorovits B; Morimoto A
AAPS J; 2013 Jul; 15(3):852-5. PubMed ID: 23620231
[TBL] [Abstract][Full Text] [Related]
7. Evaluation of pre-existing antibody presence as a risk factor for posttreatment anti-drug antibody induction: analysis of human clinical study data for multiple biotherapeutics.
Xue L; Rup B
AAPS J; 2013 Jul; 15(3):893-6. PubMed ID: 23761225
[TBL] [Abstract][Full Text] [Related]
8. A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics: a European industry perspective.
Kloks C; Berger C; Cortez P; Dean Y; Heinrich J; Bjerring Jensen L; Koppenburg V; Kostense S; Kramer D; Spindeldreher S; Kirby H
J Immunol Methods; 2015 Feb; 417():1-9. PubMed ID: 25602137
[TBL] [Abstract][Full Text] [Related]
9. Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical Relevance.
Song S; Yang L; Trepicchio WL; Wyant T
J Immunol Res; 2016; 2016():3072586. PubMed ID: 27340678
[TBL] [Abstract][Full Text] [Related]
10. Investigation of pre-existing reactivity to biotherapeutics can uncover potential immunogenic epitopes and predict immunogenicity risk.
Bivi N; Moore T; Rodgers G; Denning H; Shockley T; Swearingen CA; Gelfanova V; Calderon B; Peterson DA; Hodsdon ME; Siegel RW; Higgs RE; Konrad RJ
MAbs; 2019 Jul; 11(5):861-869. PubMed ID: 31099718
[TBL] [Abstract][Full Text] [Related]
11. Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective.
Wang YM; Wang J; Hon YY; Zhou L; Fang L; Ahn HY
AAPS J; 2016 Mar; 18(2):395-403. PubMed ID: 26721560
[TBL] [Abstract][Full Text] [Related]
12. An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox.
Schneider AK; Vainshtein I; Roskos LK; Chavez C; Sun B; Liang M
J Immunol Methods; 2016 Aug; 435():68-76. PubMed ID: 27220271
[TBL] [Abstract][Full Text] [Related]
13. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
Koren E; Smith HW; Shores E; Shankar G; Finco-Kent D; Rup B; Barrett YC; Devanarayan V; Gorovits B; Gupta S; Parish T; Quarmby V; Moxness M; Swanson SJ; Taniguchi G; Zuckerman LA; Stebbins CC; Mire-Sluis A
J Immunol Methods; 2008 Apr; 333(1-2):1-9. PubMed ID: 18275969
[TBL] [Abstract][Full Text] [Related]
14. Evaluating and Mitigating the Immunogenicity of Therapeutic Proteins.
Sauna ZE; Lagassé D; Pedras-Vasconcelos J; Golding B; Rosenberg AS
Trends Biotechnol; 2018 Oct; 36(10):1068-1084. PubMed ID: 29908714
[TBL] [Abstract][Full Text] [Related]
15. Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.
Wadhwa M; Knezevic I; Kang HN; Thorpe R
Biologicals; 2015 Sep; 43(5):298-306. PubMed ID: 26144595
[TBL] [Abstract][Full Text] [Related]
16. Scientific and regulatory considerations on the immunogenicity of biologics.
Shankar G; Shores E; Wagner C; Mire-Sluis A
Trends Biotechnol; 2006 Jun; 24(6):274-80. PubMed ID: 16631266
[TBL] [Abstract][Full Text] [Related]
17. Cross-reactive and pre-existing antibodies to therapeutic antibodies--Effects on treatment and immunogenicity.
van Schie KA; Wolbink GJ; Rispens T
MAbs; 2015; 7(4):662-71. PubMed ID: 25962087
[TBL] [Abstract][Full Text] [Related]
18. Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics.
Jawa V; Joubert MK; Zhang Q; Deshpande M; Hapuarachchi S; Hall MP; Flynn GC
AAPS J; 2016 Nov; 18(6):1439-1452. PubMed ID: 27450229
[TBL] [Abstract][Full Text] [Related]
19. Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development.
Lu Y; Khawli LA; Purushothama S; Theil FP; Partridge MA
J Immunol Res; 2016; 2016():8141269. PubMed ID: 27642612
[No Abstract] [Full Text] [Related]
20. Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies.
MacLachlan TK; Kronenberg S; Marshall N; Andrews L; Berens SJ; Brouta F; Fogal B; Freebern W; Herzyk D; Kamperschroer C; Kiessling A; Schneidkraut M; Maier C
Regul Toxicol Pharmacol; 2021 Feb; 119():104825. PubMed ID: 33220389
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]