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Bioanalysis

Home / Bioanalysis
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bioanalysis
Bioanalytical Services Overview

Bioanalysis

Whether your focus is small molecules, protein biotherapeutics, vaccines, gene therapy or cell therapy, QPS provides a full range of bioanalytical services to support drug development needs from discovery, through clinical development and regulatory filing.

Our dedicated, experienced team ensures that drug quantitation studies meet all timelines and regulatory requirements. QPS provides high quality data along with direct access to our technical staff, regularly scheduled updates in a format that works for you, and prompt and courteous answers to your inquiries. Our scientists come from a variety of backgrounds and can confidently perform the pharmacokinetic (PK), biodistribution, pharmacodynamic (PD), immunogenicity, biomarker or pharmacogenomics (PGx) experiments as required by the study protocols.

At QPS, translational medicine brings together leading-edge technologies and pharmaceutical research and development (R&D) experience to create a business service unit that works efficiently to advance your drug development program.

QPS maintains four advanced bioanalytical facilities in the USA, Netherlands, Taiwan, and India, offering strategic solutions to companies wishing to complete studies. All our facilities are geared for bioanalysis of samples containing up to biosafety level 2 (BSL 2) agents, such as human immunodeficiency virus (HIV), Hepatitis virus A, B, C, D, and E (HAV, HBV, HCV, HDV, HEV), influenza virus, coronavirus (SARS CoV, MERS CoV, SARS CoV 2). Benefit from the worldwide resources that a bioanalytical contract research organization brings, including a portfolio of assays to cover your global demand for bioanalysis for your clinical studies.

Bioanalytical services

Method Development

QPS works with you as a bioanalytical contract research organization to develop assays on the most appropriate technology platform. Prior to starting any method development, we review and discuss with you the assay requirements and intended use, such as:

  • Lead Optimization vs. Candidate Selection vs. Regulated Bioanalysis
  • Ultra-high-performance liquid chromatography–mass spectrometry (UPLC MS/MS) for small molecule drug candidates and their potential metabolites
  • Ligand Binding Assay (LBA) or hybrid UPLC MS/MS for peptide and protein drugs
  • Hybridization LBA or hybridization HPLC fluorescence or UPLC coupled to high-resolution mass spectrometry (UPLC HRMS) or UPLC-MS/MS or HPLC ultraviolet (UV) for oligonucleotide based drugs
  • Reverse Transcription – Quantitative Polymerase Chain Reaction (RT qPCR/qPCR) for mRNA (biotherapeutics and viral or plasmid vectors)

Our staff has considerable experience with conventional matrices (plasma, serum, whole-blood, urine, feces), as well as various animal and human tissues for biodistribution or potential target organ penetration or toxicity.

Bioanalytical services

Regulated Bioanalysis

QPS complies with Good Laboratory Practice (GLP) regulations and guidance documents of the U.S. Food and Drug Administration (US FDA), the Organization for Economic Co-operation and Development (OECD), the National Medical Products Administration in China (NMPA), and Pharmaceuticals and Medical Devices Agency in Japan (PMDA) as required, and incorporates global GLP principles and regulations to improve chances of a successful submission and smooth the way for regulatory acceptance.

QPS builds robust assays for regulated bioanalysis that are validated in accordance with regulations. Once the methods, data, and results have been verified, a Quality Assurance Statement is included in every final report.

Links to Relevant Documents

  • Hybrid LC-MS/MS Competence Sheet
  • Hybrid LC-MS/MS Competence Sheet
  • Bioanalysis Overview
  • Bioanalysis Overview
  • Alphabetic Assay List
  • Alphabetic Assay List
  • Drug Assay List
  • Drug Assay List
  • Biochemical Biomarker Assay List
  • Biochemical Biomarker Assay List
  • Genomic Biomarker Assay 
  • Genomic Biomarker Assay 
  • ICP-MS Competence Sheet
  • ICP-MS Competence Sheet
  • LC-MS/MS Small and Large Molecules
  • LC-MS/MS Small and Large Molecules
  • QPS Bioanalysis Milestones
  • QPS Bioanalysis Milestones
Integrity and stewardship

Leadership

Forming strategic relationships with today’s leading pharmaceutical companies requires a consistent record of client satisfaction, scientific leadership and proven results. QPS brings all of these pillars, plus a foundation of integrity and stewardship, to every partnership.

MEET OUR KEY SCIENTISTS:

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Zamas Lam, PhD

SVP, Global Head of Bioanalytical (Mass Spec) & Preclinical Development
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John Kolman, PhD

Sr. VP, Global Head of Translational Medicine
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Hui Zhang

Executive Director, Translational Medicine
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Marion Kranenborg, Ph.D.

Sr. Director

Time is of the essence in Drug Development.

Contact the QPS Business Development Team Today!

Your link to a rewarding career.

Join the QPS team and be part of our growing organization.

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About qps

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  • Mission, Vision, and Values
  • QPS History
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Preclinical Services

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  • DMPK
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  • Toxicology
  • Assay Finder
  • DMPK
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Clinical Services

  • Early Phase Clinical Trials
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  • Therapeutic Areas
  • Early Phase Clinical Trials
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  • Milestones
  • Scientific Posters
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Headquarters Location

Delaware Technology Park,
3 Innovation Way,
Newark, DE 19711

  • +1 512 350 2827
  • +1 302 369 5602
  • info@qps.com

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