Detalhe da pesquisa
1.
Determination of label efficiency and label degree of critical reagents by LC-MS and native MS.
Anal Biochem
; 664: 115033, 2023 03 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-36584741
2.
Pharmacokinetics and immunogenicity investigation of a human anti-interleukin-17 monoclonal antibody in non-naïve cynomolgus monkeys.
Drug Metab Dispos
; 43(5): 762-70, 2015 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-25739974
3.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Bioanalysis
; 16(7): 77-119, 2024 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-38389403
4.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Bioanalysis
; 15(14): 773-814, 2023 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-37526071
5.
Characterization of the robust humoral immune response to GSK2618960, a humanized anti-IL-7 receptor monoclonal antibody, observed in healthy subjects in a Phase 1 study.
PLoS One
; 16(3): e0249049, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-33755713
6.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 24(1): 4, 2021 12 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-34853961
7.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33533276
8.
Immunogenicity of Golimumab and its Clinical Relevance in Patients With Ulcerative Colitis.
Inflamm Bowel Dis
; 25(9): 1532-1540, 2019 08 20.
Artigo
em Inglês
| MEDLINE | ID: mdl-30753466
9.
Report on the AAPS Immunogenicity Guidance Forum.
AAPS J
; 21(4): 55, 2019 04 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-30993501
10.
Detection of Memory B Activity Against a Therapeutic Protein in Treatment-Naïve Subjects.
AAPS J
; 20(3): 51, 2018 03 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-29549534
11.
Recombinant Listeria vaccines containing PEST sequences are potent immune adjuvants for the tumor-associated antigen human papillomavirus-16 E7.
Cancer Res
; 64(24): 8821-5, 2004 Dec 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-15604239
12.
Immunogenicity and biomarkers: bioanalytical challenges and considerations.
Bioanalysis
; 9(22): 1729-1732, 2017 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-29120234
13.
Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics.
J Pharm Biomed Anal
; 54(2): 351-8, 2011 Jan 25.
Artigo
em Inglês
| MEDLINE | ID: mdl-20863644
14.
Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics.
J Pharm Biomed Anal
; 55(5): 878-88, 2011 Jul 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-21531522
15.
Intradermal vaccination of MUC1 transgenic mice with MUC1/IL-18 plasmid DNA suppresses experimental pulmonary metastases.
Vaccine
; 25(17): 3338-46, 2007 Apr 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-17292519
16.
A MUC1/IL-18 DNA vaccine induces anti-tumor immunity and increased survival in MUC1 transgenic mice.
Vaccine
; 24(16): 3340-52, 2006 Apr 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-16472547
17.
Engineering human IL-18 with increased bioactivity and bioavailability.
Cytokine
; 34(1-2): 114-24, 2006 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-16750378