QPS Delaware

Core Competencies

• Small molecules and peptides bioanalysis
  LC-MS/MS.
• 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).

Facility

• 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 -70^oC freezers.
• Fifty six -20^oC freezers.

Achievements

• 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.

Accreditation

• 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).

Experience

• 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.