A PHASE I FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC (PK) PROPERTIES OF THE INTRAVENOUSLY(IV) ADMINISTERED OMN6, A NOVEL ANTIMICROBIAL PEPTIDE TARGETING ACINETOBACTER BAUMANNII (A. BAUMANNII), IN ADULTS INCLUDING OLDER HEALTHY VOLUNTEERS (HVs) SUBJECTS
Acinetobacter baumannii (A. baumannii) is an opportunistic Gram-negative pathogen that is listed as of critical priority on the World Health Organization (WHO) Priority Pathogen list.
RESULTS OF A PHASE 1 CLINICAL TRIAL TO DETERMINE THE SAFETY AND TOLERABILITY OF GH002
Mebufotenin, also known as 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), is a potent psychedelic drug belonging to a group of psychoactive indole-alkylamine drugs.
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.
