QPS Delaware

Core Competencies

• Small molecules bioanalysis:
  LC-MS/MS.
• Translational medicine (large molecule) (TLM):
  PK, ADA, biomarkers, cell-based NAb assay, cell-based potency assay over ELISA/Bio-Plex/cell assay platforms, genetic analysis, qRT-PCR, as well as state-of-the-art LC-MS/MS methods for peptides and proteins.
• Drug metabolism and pharmacokinetics (DMPK):
  Discovery LC-MS/MS bioanalysis, oligonucleotides LC-MS/MS bioanalysis, protein binding, CYPs and transporters, PK/TK, metabolite identification, mass balance, and whole-body autoradiography, etc, 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.

Facility

• 30,000 square feet of bioanalytical (small molecule) facilities (Newark, Delaware); 24,000 square feet of translational medicine facilities (Newark, Delaware); 16,500 square feet of DMPK facilities (Newark, Delaware); and 5,000 square feet of DTRL facilities (Fargo, North Dakota).
• Bioanalytical, biochemical, radionuclide, and microbiological laboratories.
• AB Sciex triple-quad mass spectrometer platform with Nexera UHPLC front-ends and Tomtec automated liquid handlers: bioanalytical (API 4000, API 5000, API 6500); TLM (API 6500, API 6500 Q-Trap); DMPK (API 4000, API 5500 Q-Trap, API 5600 High Resolution, API 6600); and DTRL (API 3000).
• VersaMax microplate readers, SpectraMax multi-mode plate reader, Meso Scale Discovery S 600 ECL, Gyrolab xPlore, Quanterix SR-X.
• Gamma and beta counters, radio flow detector, 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.

Achievements

• At least 260 client audits completed.
• 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).
• 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 of experience in the development, implementation, and validation of quantitative LC-MS assays for small molecules, peptides, proteins, and oligonucleotides, employing multiple bioanalytical platforms.
• Over 15 years of development, implementation, validation of ligand-binding, hybridization, and enzymatic assays for the quantification of biopharmaceuticals and biomarkers in complex biological matrices.
• Over 30 years of dermal and transdermal safety, BA, BE, and in vitro pharmacokinetics experience.