If studies indicate that the oligonucleotide therapeutic could modulate CYP enzymes or transporters, the sponsor should consider clinical studies to evaluate in vivo drug interactions.

Monitoring cellular immune responses during drug development and clinical trials is critical for assessing the safety and efficacy of therapeutic interventions. Flow cytometry–based intracellular cytokine staining (ICS) and ELISpot assays are widely used for this purpose, each with distinct advantages and limitations.

QPS, LLLC and Boehringer Ingelheim Pharmaceuticals, Inc. collaborated to develop a robust cell-based method to detect and titer nAb responses in patient sera to support clinical development of an oncolytic rhabdovirus and cancer vaccine platform based on the VSV-GP virus. This Poster is one of the winners of the 20th WRIB Poster Award.

The QPS study was conducted to investigate the metabolism ZD10Q in the Sprague Dawley rat, Beagle dog, Cynomolgus monkey, and human using pooled cryopreserved hepatocyte suspensions.

QPS used three commercial double stranded siRNA drugs in a series of inter-species, in vitro, qualitative and quantitative metabolite characterization experiments using modified small molecule procedures to confirm internal process to establish similar confidence for MIST.

With the increasing requirements for monitoring cellular immune responses during clinical trials, QPS previously developed a comprehensive 40-color high-dimensional flow cytometry panel to assess various cellular immune responses.

QPS and GH enrolled healthy volunteers for a Phase I trial to determine the safety and tolerability of a single administration or a single-day IDR of GH001.

Three Phase I studies in healthy volunteers were conducted to monitor KIT inhibitor depletion in mast cell tissues to determine it’s effectiveness in mast cell driven diseases.

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).

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.

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.

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.

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.