320 results on '"Gorovits, Boris"'
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2. Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab
3. Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy
4. Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation
5. Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling
6. When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform
7. Detection of Humoral Response to Transgene Protein and Gene Editing Reagents
8. Bioanalytical Methods to Detect Preexisting and Post‐administration Humoral Immune Responses Against AAV Capsid Proteins
9. Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics
10. Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays
11. Understanding Bioanalysis Regulations
12. Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics
13. 2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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)
14. Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics
15. Development of a Highly Specific Anti-drug Antibody Assay in Support of a Nanoparticle-based Therapeutic
16. Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence
17. Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays
18. Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays
19. Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population
20. Unwanted Immunogenicity Responses to Biotherapeutics
21. Factor Xa
22. Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling
23. Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis
24. Anti-drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points
25. Report on the AAPS Immunogenicity Guidance Forum
26. Induction and Impact of Anti-Drug Responses Elicited by a Human Recombinant Coagulation Factor FXaI16L in Preclinical Species
27. Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody
28. Approaches to Resolve False Reporting in Neutralizing Antibody Assays Caused by Reagent Leaching from Affinity Capture Elution Solid Phase
29. Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development
30. Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies
31. Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint
32. Pharmacokinetics, Biodistribution and Anti-CD19 CAR Expression Kinetics in Vitro and after In Vivo Delivery of a CD8-Targeted Fusosome in NSG Mice
33. Understanding Bioanalysis Regulations
34. A Simple Approach to Determine a Curve Fitting Model with a Correct Weighting Function for Calibration Curves in Quantitative Ligand Binding Assays
35. Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology
36. Pre-existing Antibody: Biotherapeutic Modality-Based Review
37. Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves
38. Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
39. 2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)
40. Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates
41. Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
42. In Vivo Delivery of a CD20 CAR Using a CD8-Targeted Fusosome in Southern Pig-Tail Macaques (M. nemestrina) Results in B Cell Depletion
43. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)
44. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
45. Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation
46. Pre-Existing Biotherapeutic-Reactive Antibodies: Survey Results Within the American Association of Pharmaceutical Scientists
47. Proposed mechanism of off-target toxicity for antibody–drug conjugates driven by mannose receptor uptake
48. Feasibility of singlicate-based analysis in bridging ADA assay on Meso-Scale Discovery platform: comparison with duplicate analysis
49. Hypoimmune, Allogeneic CD22-Directed CAR T Cells That Evade Innate and Adaptive Immune Rejection for the Treatment of Large B Cell Lymphoma Patients That Are Relapsed/Refractory to CD19-Directed CAR T Cell Therapy
50. Phase 1 Study of SC291, a Hypoimmune, Allogeneic CD19-Directed CAR T Cell Therapy for Relapsed/Refractory B-Cell Malignancies (ARDENT) - Initial Clinical Data
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