CHOOSING AN APPROPRIATE NEUTRALIZING ANTIBODY ASSAY FORMAT: A CASE STUDY IN PARALLEL METHOD DEVELOPMENT OF CELL-BASED AND COMPETITIVE LIGAND BINDING NEUTRALIZING ANTIBODY ASSAYS
The 2019 FDA Immunogenicity Guidance, and Wu, et. al., recommend using a cellbased assay format for neutralizing antibody (NAb) assays when a therapeutic has a cell-based mechanism of action (MoA).
A 40-COLOR HIGH DIMENSIONAL FLOW CYTOMETRY PANEL TO EVALUATE CELLULAR IMMUNE RESPONSES ON VARIOUS T-CELL SUBSETS FROM CRYOPRESERVED HUMAN PERIPHERAL BLOOD MONONUCLEAR CELLS
With the ongoing outbreak of the coronavirus disease COVID-19 in recent years, there has been increased interest into better understanding an individual’s cellular immunity to COVID-19 or any other vaccine or gene therapeutic agent.
A SENSITIVE LC-MS/MS METHOD FOR RELUGOLIX QUANTIFICATION IN HUMAN PLASMA AND ITS APPLICATION TO A CLINICAL STUDY
QPS collaborated with Sumitomo Pharmaceuticals America Inc. to develop and validate a sensitive LC-MS/MS method for relugolix quantification in human plasma and its application to a clinical study.
DOUBLY HYPHENATED METHOD (LC-MS/MS-FLUOROMETRIC) FOR DETERMINATION OF NUCLEOSIDE TRIPHOSPHATES AND ANALOGS IN PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMCs)
QPS collaborated with Gilead Sciences, Inc. to validate a method to measure FTC-TP and TFV-DP levels in human PBMCs, using gDNA-calibrated PBMC counts to express results in ng per million cells.
A PHASE I FIRST-IN-HUMAN STUDY IN HEALTHY VOLUNTEERS WITH INTRAVENOUSLY ADMINISTERED OMN6, A NOVEL ANTIMICROBIAL PEPTIDE TARGETING ACINETOBACTER BAUMANNII
QPS worked closely with Omnix Medical Ltd. to present the results of a Phase I first-in-human study in healthy volunteers with intravenously administered OMN6.
PHASE 1 EVALUATION OF THE SAFETY, TOLERABILITY AND PLASMA AND CSF PHARMACOKINETICS OF AST-004 AFTER IV INFUSION IN HEALTHY VOLUNTEERS
Peter Dogterom, PhD presents the Phase 1 evaluation of the safety, tolerability and plasma and CSF pharmacokinetics of AST-004 after IV infusion in healthy volunteers.
RELATIVE BIOAVAILABILITY AND FOOD EFFECT STUDY WITH A NEW TABLET FORMULATION OF SELVIGALTIN (GB1211) IN HEALTHY VOLUNTEERS
Peter Dogterom, PhD presents the relative bioavailability and food effect study with a new tablet formulation of selvigaltin (GB1211) in healthy volunteers.
EXPERIENCES OF CSF COLLECTION BY SERIAL SAMPLING OR LUMBAR PUNCTURE IN CLINICAL PHARMACOLOGY RESEARCH
Peter Dogterom, PhD presented Experiences of CSF collection by serial sampling or lumbar puncture in clinical pharmacology research at ASCPT 2023 in March 2023.
