Whether your focus is small molecules, protein biotherapeutics, vaccines, or gene therapy, QPS provides a full range of bioanalytical solutions to support all of drug development from discovery, through clinical development and filing.
Our dedicated, experienced team ensures that drug quantitation studies meet all timelines and requirements. QPS provides high quality data at competitive prices, 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), pharmacodynamic (PD), immunogenicity assessment or pharmacogenomics (PGx) experiments required by your design.
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 with sites or trials overseas and/or wishing to complete 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.
QPS works with you to develop assays on the most appropriate technology platform. Before any method development work begins, we sit down with you to review and discuss the assay requirements and intended use, such as:
- Lead optimization vs. Candidate Selection vs. Regulated Bioanalysis.
- Liquid chromatography–mass spectrometry (LC-MS/MS) for small molecule drug candidates and their potential metabolites.
- Ligand Binding Assay (LBA) or LC-MS/MS for peptide and protein drugs.
- Ultra-high-performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS) or hybridization-HPLC-fluorescence or HPLC-ultraviolet (UV) or hybridization-LBA 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.
QPS complies with Good Laboratory Practice (GLP) regulations and guidance documents of the U.S. Food and Drug Administration, and incorporates global GLP principles and regulations to improve chances of a successful submission and smooth the way for regulatory acceptance.
Once the methods, data, and results have been verified, a Quality Assurance Statement is included in every final report. QPS builds robust assays for regulated bioanalysis that are validated in accordance with regulations.
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.
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