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QPS, LLC

7 Orders Completed
Newark, Delaware, US

About QPS, LLC

Divison of: QPS Holdings, LLC

Founded in 1995, QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide. Our linearly integrated core competencies include: - Neuropharmacology - DMPK - Toxicology - Bioanalysis - Translational medicine - Early Stage Clinical Research - Phase II – IV Clinical Research - Program Management Our regional laboratories and testing facilities are located at our headquarters in Newark, DE, USA; Springfield, MO, USA; Miami, FL, USA; Groningen, The Netherlands; Graz, Austria; Hyderabad, India and Taipei, Taiwan.

Diversity Certificates

Minority owned business

Our Services (58)


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IND-Enabling Studies

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Tissue Sectioning

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Bioanalysis

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Whether your focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides you with a full range of bioanalytical solutions to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies.

Our dedicated, skilled and experienced staff ensures that PK drug quantitation studies meet sponsor's requirements and timelines. In addition to timely, high quality data at competitive prices, QPS provides you with direct access to our technical staff, regularly scheduled updates in a format that works for you and prompt, courteous answers to your inquiries.

QPS maintains four advanced bioanalytical facilities in the USA, Netherlands, Taiwan and India, offering strategic solutions to companies with sites or trials overseas and/or wishing to complete off-shore studies in Asia and/or India. Benefit from our worldwide resources through which a portfolio of assay principles is offered to cover your entire global demand in bioanalysis for your clinical studies.


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Ligand Binding Assays

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QPS is at the forefront of a wide range of ligand binding assays for a variety of discovery research and drug development studies. Our scientists have extensive experience in the development and validation, under GLP guidelines, of immunoassays and various technology platforms. Our in-depth technical expertise enables us to offer our clients project-based and cost-effective immunoassay services, including:

  • Assay development with ELISA, colorimetric, fluorescence, chemiluminescence and MSD electrochemiluminescence (ECL)detections
  • Assay validation under GLP regulations for PK and Immunogenicity assessment
  • Sample analysis of proprietary test article concentration or anti-drug antibody (ADA) in biological matrices.
  • Support preclinical and clinical biological drug development programs as well as monoclonal antibody screening and discovery


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LC-MS/MS

Liquid chromatography tandem mass spectrometry
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LC-MS/MS is the method of choice for small molecule drug quantitation because, by definition, any molecules that can be ionized and detected can be quantitated using LC-MS/MS. Although most of the LC-MS/MS methods developed and validated by QPS are for traditional small molecule drugs, we have also developed and validated LC-MS/MS assays for large multiple-charged molecules such as polypeptides and oligonucleotides.

QPS has significant experience with various chemical structures in multiple therapeutic areas. With the increasing emphasis on "active" isomers and "active" metabolites, over 80% of our NCE studies are in the "N-in-1" format and about 15% of our new assays are chiral studies.

Equipment

QPS currently has 30 LC-MS/MS instruments between QPS Delaware and QPS Taiwan operations. QPS Delaware has 19 API 4000 triple quadrupoles mass spectrometers, as well as UPLC, LC/UV and LC/fluorescent instruments dedicated to regulated studies. Seven other LC-MS/MS instruments, including six API 4000 triple quadrupoles and linear ion trap, are dedicated to discovery, non-regulated and metabolite identification studies. QPS Taiwan has four API 4000 triple quadrupoles for bioanalysis studies.


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Liquid Chromatography (LC)

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  • LC-MS/MS or LC-HRMS for small molecules, polypeptides, oligonucleotides, as well as proteins and antibody therapeutics
  • LC-Radio Flow Detection (RFD) for human and animal mass balance/excretion studies


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qPCR

Quantitative PCR
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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Studies determining Absorption, Distribution, Metabolism and Excretion (ADME) patterns in laboratory animals and humans are an integral part of the Drug Metabolism and Pharmacokinetics (DMPK) services provided by QPS. These studies are employed at the discovery, candidate selection, Investigational New Drug (IND) enabling and New Drug Application (NDA) stages of a development program.

Many New Chemical Entities (NCEs) can be rapidly screened using the discovery Pharmacokinetics (PK) approach, resulting in more efficient identification of candidates with the most desired ADME properties. By optimizing the lead structures during the candidate selection process, QPS helps to select drug candidates with the best chance of success. Completion of the preclinical DMPK and clinical PK studies will provide an ADME data package that will fully support regulatory IND and NDA submission.

In addition to conducting animal PK studies, QPS performs a comprehensive series of biotransformation and Quantitative Whole-Body Autoradiography (QWBA) studies.


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Quantitative Whole Body Autoradiography (QWBA)

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QWBA offers unique insights for investigators by answering key questions related to tissue pharmacokinetics and metabolism, pathology, toxicology, drug delivery and disposition. QWBA studies provide the tissue distribution and pharmacokinetics data required for new drug registration and for predicting human exposure to radioactivity during clinical radiolabeled mass balance studies.


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Plasma Protein Binding

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Plasma protein binding in rodent, non-rodent and human

  • Use ultrafiltration or equilibrium dialysis
  • Determine the extent of binding to plasma proteins
  • Select the candidate with the highest free fraction

Rodents Human

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CYP Induction Assay

Price on request

QPS provides drug interaction studies to determine the potential of a substance to alter cytochrome P450 activity. Studies conducted to assess inhibition and induction potential to support discovery and development of new drug candidates are:

  • In vitro inhibition characterization in human liver microsomes or hepatocytes to determine reversible or time dependent IC50
  • In vitro mechanistic characterization of reversible inhibitory rate constants, K i Identify the reversible mechanism of inhibition as competitive, non competitive or uncompetitive
  • In vitro mechanistic characterization of time dependent inhibition, K inact and K I
  • Identify the mechanism of time dependent inhibition as metabolite mediated via covalent modification or due to tight binding effect of substrate
  • In vitro characterization of CYP1A2, CYP2B6, and CYP3A4 induction potential in human hepatocytes based on mRNA and/or CYP activity using isoform selective probe substrates


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CYP Inhibition Assay

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In vitro inhibition of CYP in human liver microsomes (determine IC50)

  • Utilizing isoform selective probe substrates to assess inhibition potential of lead structure(s) to inhibit activity of human CYPs (reversible and time dependent)
  • Rank order of lead compounds based on potential to inhibit the CYPs
  • Select the candidate with the lowest potential to cause metabolism-based clinical drug-drug interactions and devoid of time dependent inhibition


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Reaction Phenotyping

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In vitro reaction phenotyping using both recombinant CYPs or UGTs or other enzyme systems and human liver microsomes and chemical inhibitors using non-labeled and radio-labeled test articles


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In vitro Metabolic Stability Assays

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In vitro metabolic stability in hepatic subcellular fractions to determine intrinsic clearance.


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Drug Transporter Assays

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Toxicology

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Phase I Clinical Trials

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In vitro ADME/DMPK Studies

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In vitro ADME Services


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Pharmacology & Toxicology

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Pharmacology & Toxicology Services


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Clinical Trials, Consulting, and Management

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Clinical Trials, Consulting, and Management Services


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Clinical Research

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Clinical Research Services


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Radiography

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Radiography Services


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Imaging & Spectroscopy

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Imaging & Spectroscopy Services


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Chromatography

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Chromatography Services


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Separation/Purification Services

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Purification Services


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Analytical Chemistry Services

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Analytical Chemistry Services


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Chemistry and Materials

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Chemistry and Materials Services


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Biomolecular Interaction Analysis

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Biomolecular Interaction Analysis Services


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Liquid Chromatography Coupled Mass Spectrometry Methods

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Liquid Chromatography Coupled Mass Spectrometry Methods Services


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Mass Spectrometry

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Mass Spectrometry Services


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Spectroscopy

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Spectroscopy Services


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PCR

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PCR Services


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DNA Services

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DNA Services


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Nucleic Acid Services

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Nucleic Acid Services


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Biochemistry & Molecular Biology

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Biochemistry & Molecular Biology Services


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Biology

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Biology Services


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In vitro Disease Models

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Cells and Tissues

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Cells and Tissues Services


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Biospecimens

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Biospecimens Services


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Tissue Processing

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Tissue Processing Services


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Clinical Molecular Diagnostics

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Clinical Laboratory Services

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Drug Discovery & Development

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Bioanalytical Assays

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Bioanalytical Analysis LC/MS/MS

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In vitro Bioavailability/Bioequivalence Studies

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Biomarker Discovery

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Contract Research

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Drug Discovery

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Clinical Genomic Testing

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Animal Model in vivo Analyses

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Pharmacogenomics/Pharmacogenetics

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In vivo Drug Efficacy Testing

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Contract Services Directory

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Biomarkers

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Assay Development

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Project Management

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Animal Models and Studies

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MG

MaryAnn Gagnon

Head of the QPS Global Proposal Office
JG

Jerry Gromelski

Senior Director of Business Development

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