Digital Learning
Scientific Posters
SOT, 2024
Comparison of Changes of Hematology & Coagulation in Fasted & Non-fasted Non-Human Primates
SOT, 2024
Retrospective Review of Tolerable Levels for Polyethylene Glycol in Non-Clinical Studies as a Vehicle Component
SOT, 2024
Establishment of Preclinical Immunotoxicity Reference Based on a Large-scale Immunophenotyping Data in Cynomolgus Monkey
AAPS, 2023
Validation Of An In Vitro Cell-based Assay For The Detection Of Neutralizing Antibodies Against Adeno-associated Virus 9 In Cynomolgus Monkey
AAPS, 2023
Comparison of Branched DNA (B-DNA) and Reverse Transcription-Polymerase Chain Reaction (RT-qPCR) Method Validation for the Quantification of mRNA Therapeutics in Plasma
AAPS, 2023
A Comprehensive Bioanalytical Strategy of In Vivo Studies for RNAi Therapeutics in Early Discovery
AAPS, 2023
Metabolite Identification of Nucleoside Analog Prodrugs in Biological Matrix by Derivatization Coupled with Radio-Detector and Mass Spectrometry
AAPS, 2023
Research Strategy of Chiral PROTACs in Discovery Stage Based on Analysis Platforms of UPCC-MS/MS and UPLC-MS/MS
AAPS, 2023
Smart Compound Library Based on Machine Learning, Sensing Technology, and Programmable Logic Control
AAPS, 2023
Evidence-Based Strategies for the Characterization of New Chemical Entity (NCE) In Vitro CYP and Non-CYP Enzyme Reaction Phenotyping at the Development Stage
ISSX, 2023
Development of a Convenient In Vitro Method for Predicting Metabolism and Disposition of Acrylamide Covalent Drugs in Humans
ISSX, 2023
Novel Approach to Determine Plasma Protein Binding for Labile Compounds Using Equilibrium Dialysis
ISSX, 2023
Establishment of the Relay Method for Low Turnover Compounds in Hepatocyte Stability Assays
ISSX, 2023
Plasma Protein Binding of Oligonucleotides Using Rapid Agarose Gel Electrophoretic Mobility Shift Assay
EuroTox, 2023
Incidence of Common Arrhythmias in Bama Minipigs of Stand-Alone Safety Pharmacology and General Toxicology Studies
EuroTox, 2023
An Evaluation of Detection Sensitivity and Pharmacokinetic Profile for Conscious Telemetered Cynomolgus Monkeys
White Papers
Developing a Convenient In Vitro Method for Predicting Metabolism and Disposition of Acrylamide Covalent Drugs in Humans
Bridging Preclinical and Clinical Assays for Biologics Development –Challenges and Considerations for Phase I Trials
Webinars
Upcoming Webinars
The development of oligonucleotide-based therapeutics has recently attracted extensive attention due to their eminent potential. Oligonucleotide therapies have many advantages, including ease of design, a wide range of targets, and high specificity. However, the chemical characteristics of oligonucleotides pose a significant challenge for bioanalysis. In addition, oligonucleotides’ immunogenicity and immunotoxicity potential are of concern in pre-clinical and clinical trials. To better facilitate oligonucleotide drug development, we share some bioanalytical strategies and case studies regarding the mitigation of these challenges.
In this webinar, we explore an integrated platform for preclinical DMPK bioanalysis of ADCs and how it can help characterize the pharmacokinetic (PK) profile of each of an ADC drug’s structural components. The platform incorporates a number of different testing strategies—ligand-binding assays (LBAs), liquid chromatography mass spectrometry (LC/MS), hybrid LBA-LC/MS bioanalysis—and is divided into six parts: total antibody, conjugated antibody (ADC), free payload, metabolite identification (MetID) and major metabolites, immunogenicity, and the drug antibody ratio (DAR) evaluation. We’ll dive into each part in detail, and, along the way, review several internal validation cases of DMPK research for ADCs.