Track 2: Novel Strategies to Advance Biotherapeutic Development

(T1130-02-06) Biodistribution Analysis of GPC-3 CAR-T Cells in NSG Mice by a Universal ddPCR Assay to Support an IND-Enabling Toxicity Study

(W1130-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics ­­­– Post-Translational Modification (2) Oxidation

(T1130-02-07) Anti-CCR8 Mediated Depletion of Tumor-Infiltrating Regulatory T Cells: Preclinical PK/PD and Translational Strategy in Support of Clinical Development for Solid Tumor Indications

(W1130-02-07) Biodistribution Study of a Bivalent SARS-CoV-2 mRNA Vaccine in Rat

(T1130-02-08) Intestinal Organoid as a Predictive Model for the Assessment of Nano-Drug Delivery Systems

(W1130-02-08) Oral Absorption of Semaglutide: Pharmacokinetic Modeling and Molecular Dynamics Simulations

(W1130-02-09) Immunogenicity Risk Assessment of Salmon Calcitonin Peptide Impurities Using In Silico and In Vitro Methods

(T1130-02-10) A Novel Approach to Mechanical Characterization of Pharmaceutical Lyospheres

(W1130-02-10) Choosing the Right Bioanalytical Platform to Accommodate a Biotherapeutic Pharmacokinetic Measurement in Serum and CSF:  A Case Study

(W1130-02-11) Comparison of a Microfluidic Generic Total Antibody (TAb) Assay with Independent Neutralizing Antibody (NAb) and TAb Assays for the Detection of Pre-existing Antibodies against AAV Vectors

(T1130-02-11) Rapid and Predictive Immunogenicity Risk Assessments Using In Silico Methods

(T1230-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Overview

(W1230-02-06) Strategies for the Development and Characterization of Sensitive Anti-oligonucleotide Antibodies for Application in Anti-drug Antibody Assays

(T1230-02-07) A Validated Immunocapture LC-MS/MS Hybrid Assay for the Quantitation of a Novel Multi-Domain Therapeutic Protein in Human Plasma with Clinical Sample Analysis

(W1230-02-07) Docetaxel and QDs Based Nano Lipidic Theragnostic System for Cure and Real-Time Monitoring of Breast Cancer: Efficacy and Safety Studies in Rats

(T1230-02-08) Quantitation of Soluble Tumor-Associated Antigens (sTAA) in Tumor Interstitial Fluid (TIF) Isolated from Frozen Solid Tumors

(W1230-02-09) LC-MS FFPE Tissue Analysis Across Multiple Murine Tissues Supports Mouse Relevance for On-Target/Off-Tumor Toxicity Assessment for Anti-STEAP2 CAR-T Therapeutic Development

(T1230-02-09) Population Pharmacokinetics and Exposure-Efficacy and -Safety Analyses of Atezolizumab for Subcutaneous Injection in Patients with Locally Advanced or Metastatic Non-small Cell Lung Cancer

(T1230-02-10) Development of a Highly Sensitive Immunoassay to Measure Circulating Levels of a Nanobody-Based Imaging Agent

(W1230-02-10) Qualification of a 48-plex Cytokine Olink Panel to Support Rare Disease and Pediatric Clinical Studies

(W1230-02-11) Comprehensive Assessment of Immunogenicity Risk of Host Cell Proteins in Biologics and Vaccines Using In Silico and In Vitro Methods

(T1230-02-11) Sensitive Quantitation of Antisense Oligonucleotides Using Capitainer^® qDBS Microsampling Device Coupled with Hybridization LC-MS/MS

(W1330-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (1) Deamidation

(T1330-02-06) Utilizing a Bead-Based Sample Pretreatment to Overcome Drug Interference in Developing a Ligand Binding Neutralizing Antibody Assay

(T1330-02-07) Optimizing and Validating an In Vitro Transcytosis Assay for Predicting Pharmacokinetics in Drug Discovery and Process Development

(T1330-02-08) Production and Characterization of Critical Biotin and DIG Conjugated RESCA-Anti-CD8 VHH Reagents to Enable the Non-Clinical and Clinical Anti-Drug Antibody Assay Development

(W1330-02-09) Using Cryo-TEM to Characterize Structural Details of LNPs during Manufacturing

(W1330-02-10) Next-Generation Biocompatible HPLC System for Enhanced Analysis of Biotherapeutics

(T1330-02-10) Novel Immunoassay Technology: Evaluating the PIXI Platform for Rapid Quantitation with Automation, Wide Dynamic Range, and Small Sample Volume Requirement

(T1330-02-11) Oligonucleotide Dual Hybridization Assay Using Offline Pre-incubation followed by an Automated Microfluidic Method

(W1330-02-11) One Drop of Blood, Multiple Sets of Data --- Establishing A Common Protocol for Serotype Specific IGG Concentration Testing Using Mitra® VAMS Dry Blood Samples to Support Vaccine Clinical Studies

(W1430-02-06) Application of a Novel Affinity Purified Chicken IgY in an Immunoaffinity LC-MS/MS Assay for Rapid Quantitation of Monoclonal Antibody Therapeutics and ADCs in Nonclinical Species

(T1430-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (1) C-terminal Lys Clipping

(T1430-02-07) Analysis of Glucagon-Like Peptide-1 (GLP-1) Analog in Rat Plasma Using an LC-MS/MS Workflow

(W1430-02-07) Novel Use of Recombinant Dimeric IgA Monoclonal Antibodies as Cyst-Targeted Therapeutics in Polycystic Kidney Disease

(W1430-02-08) In Vitro Method Using Circulating Tumor Cells-Derived Organoids from Patients with Solid Tumors to Transform Oncology Drug Development

(T1430-02-08) Leveraging Buprenorphine as a Tool Molecule to Develop a Novel PBPK Model Accounting for Intestinal Lymphatic Absorption

(T1430-02-09) Bridging Bevacizumab PK from Adults to Pediatrics through PBPK Modeling

(W1430-02-09) Exploring the Future Potentials of High-Resolution Mass Spectrometry for Regulated Bioanalysis

(T1430-02-10) A Novel In Vitro Serum Stability Assay for Antibody Therapeutics Incorporating Internal Standards

(W1430-02-10) Analysis of Anti-Drug Antibodies (ADA) in Multiple Animal Species from mRNA LNP Therapeutics Supporting Rare Diseases Demonstrated Low Immunogenicity of PEG-2000 by ECLA and ELISA Methodology

(W1530-02-06) Age-Dependent Reduction in Hepatic Vector Genome Loss in Juvenile OTC^spf-ash Mice Following a Single Dose of DTX301 and Partial Compensation Achieved with a Higher Dose

(T1530-02-06) Development of an Electrochemiluminescent Assay for the Detection of Anti-PEG IgE Antibodies in Human Serum

(T1530-02-07) Integrated HypoSkin® Model and PBPK Modeling as a Bioavailability Predicting Tool for Subcutaneous Delivery of Protein Therapeutics

(T1530-02-08) Cross Validation of Pharmacokinetic Assays: Experimental and Statistical Design

(W1530-02-08) Non-invasive Molecular Imaging of V3 Receptors to Localize ACTH-Dependent Cushing's Syndrome and Precision Surgery of Corticotropinoma

(W1530-02-09) Development of Non-Cell Based Potency Assays for Bispecific Antibodies

(T1530-02-09) False Positive or Not? – Assessing Potential Interference of Soluble Target to ADA Detection for a Clinical Stage Program

(W1530-02-10) An “I” (Immunogenicity Risk Assessment) for an Eye (Ophthalmology Biologics)

(T1530-02-10) Development of a Generic, Automated, Microfluidic Human IgG-FcRn Affinity Assay In-Solution for Use in Antibody Engineering

(W1530-02-11) Evaluation of API 7500 Integrated System with Microflow LC System M5 Using Sulfamethazine (SDX) Neat Solution

(T1130-02-09) Evaluation of Sample Preparation Techniques for Protein Quantification

(W1330-02-07) Enhancing Antibody Detection for PABAD-Based Neutralizing Antibody Detection and Validation

(T1330-02-09) Gyrolab Generic Anti-drug Antibody Assay Streamlines Preclinical Immunogenicity Assessment

(T1430-01-02) Enhanced Transdermal Delivery of Anticancer Agent: A Comprehensive Study on Fractional Ablative Laser