3 Innovation Way, Newark,
Delaware 19711, USA
- QPS, LLC is a GLP/GCP-compliant CRO, specializing in discovery, preclinical, and clinical drug development research.
- Located in Newark, Delaware, USA, it was established in 1995 and currently has 250+ employees.
QPS Delaware Headquarters Site Visit Information
QPS is an award winning global CRO providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services in Toxicology, DMPK, Neuropharmacology, Preclinical and Clinical Drug Development. When you visit our Newark, DE Headquarters, please use this interactive resource to help plan your trip. It includes transportation options, accommodations and activities in Delaware.
- Small molecules and peptides bioanalysis
- Translational medicine (biotherapeutics and gene therapy) (TLM):
PK, ADA, cell-based NAb assay, cell-based potency assay, biomarkers using ELISA / MSD / Gyrolab / Bio-Plex / Quanterix / cell assay platforms, genetic analysis, RT-QPCR, LC-MS/MS, and LC-HRMS methods for peptides, proteins, oligonucleotides, mRNA, and vectors. Hybrid LC-MS/MS for exploratory, screening, and regulated bioanalysis of proteins and enzymes.
- Drug metabolism and pharmacokinetics (DMPK):
Rodent PK, protein binding, quantitative whole-body autoradiography, microautoradiography, CYPs, UGTs, and drug transporters, metabolite identification and profiling, mass balance, non-regulated LC-MS/MS bioanalysis, TK calculation and reporting, with rodent vivarium.
- Clinical research services:
Project management, regulatory affairs, medical monitoring, CRA, clinical consultancy, trial logistics, legal representation, pharmacovigilance, medical writing/PK/PD/biostatistics, and data management.
- Dermal and transdermal research labs (DTRL):
In vitro pharmacokinetics, including in vitro release testing (IVRT) and in vitro permeation testing (IVPT).
- 54,000 square feet of bioanalytical facilities for small molecules, biotherapeutics, and gene therapy products (Newark, Delaware); 16,500 square feet of DMPK facility (Newark, Delaware); and 5,000 square feet of DTRL facility (Fargo, North Dakota).
- Biosafety level 2 (BSL 2) facilities to handle bioanalysis of 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), …
- Bioanalytical, biochemical, radionuclide, and cell-culture laboratories.
- Sciex mass spectrometry platform with Nexera UPLC front-ends and Tomtec automated liquid handlers: API 4000, Triple Quad 5000, Triple Quad 6500/6500+, QTrap 5500, QTrap 6500+ with SelexIon, TripleToF 5600, TripleToF 6600/6600+; and API 3000 @ DTRL.
- VersaMax microplate readers, SpectraMax multi-mode plate reader, Meso Scale Discovery S 600 ECL, Gyrolab xP, Gyrolab xPand, Gyrolab xPlore, Quanterix SR-X.
- QIAsymphony, QIAgility, PyroMark, QuantStudio 7 Flex, QuantStudio 12K Flex
- Gamma and beta counters, radio flow detector, LC-FLD/UV, LC-DAD/UV equipment, and oxidizers.
- LIMS (Laboratory Information Management System) for data management, analytical run acceptance, materials management, storage management, and equipment validations/management: Watson, Debra.
- Eighty seven -70oC freezers.
- Fifty six -20oC freezers.
- 120+ client audits completed since 2015.
- Client audits increased 54% (due to new clients/growth), while the number of client observations have decreased 49%.
- 11 US FDA inspections completed with 36% free from citations.
- 6 CLIA inspections and certifications earned.
- No agency escalation or warning letter ever received.
- No employee has been debarred or in proceedings for debarment by the US FDA.
- Animal Welfare Assurance from the Office of Laboratory Animal Welfare, National Institutes of Health, and the Department of Health and Human Services (Assurance Number: A4360-01).
- Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International / Number: 001067). Received a “Full Accreditation continued” certification in June 2021.
- Certificate of Compliance, Clinical Laboratory Improvement Amendments, Centers for Medicare and Medicaid Services (CLIA Identification Number: 08D0995854).
- Minority Business Enterprise Certification (NAICS Code: 541711), PA-NJ, DE Minority Supplier Development Council (Certificate Number: DE0463).
- Extensive validated bioanalytical assay list (1,000+ assays developed and validated in blood, serum, plasma, tissue, saliva, sputum, and formulations — and growing) for which a lower limit of quantitation of 1 pg/mL is no longer an exception.
- Over 5,000 bioanalysis studies conducted and more than 2 million samples analyzed.
- 20+ years experience in the development, implementation, and validation of quantitative LC MS/MS assays for small molecules, peptides, and biomarkers employing multiple bioanalytical platforms.
- 15+ years experience in development, implementation, and validation of ligand-binding, hybridization, enzymatic, hybrid LC MS/MS assays for the quantification of biotherapeutics and biomarkers in complex biological matrices.
- 15+ years experience in development, implementation, and validation of LC MS/MS, hybridization, LC FLD, LC UV, LC HRMS, and RT QPCR assays for the quantification of oligonucleotides, mRNA, and vectors in complex biological matrices.
- 30+ years dermal and transdermal safety, BA, BE, and in vitro pharmacokinetics experience.