QPS Netherlands

Core Competencies

• Early Phase Clinical Development:
  Phase I & IIa (i.e. FIH, PoC studies, PK studies, and radiolabeled); specialized in CNS, respiratory, women’s health, and special PK studies (CYPs and transporters); supported with scientific expertise and medical oversight, a GMP pharmacy with compounding capabilities and QP release, plus healthy volunteer and patient recruitment.
• Clinical Research Services
  Project management, regulatory affairs, medical monitoring, CRA, QA, clinical consultancy, trial logistics, legal representation, pharmacovigilance, medical writing/PK/PD/biostatistics, and data management.
• Small Molecule and Elemental Bioanalysis:
  LC-MS/MS, ICP-MS, LC-ICP-MS, and ELISA-ICP-MS; radionuclide laboratory (D-lab) to support human AME studies and radioimmunoassay (RIA).
• Biotherapeutics Bioanalysis:
  PK, ADA, biomarkers, cell-based Nab assay, cell-based potency assay using ELISA / MSD / Gyrolab / cell assay platforms, LC-MS methods for peptides, proteins, ADC’s and oligonucleotides. Immunoaffinity LC-MS/MS for exploratory, screening, and regulated bioanalysis of proteins and enzymes.

Facility

• 58 hospital-based Phase I study beds; refrigerators, synchronized clocks, freezers (-20/-80/-196), emergency call system, centrifuges, IV-pump, spirometry, ECG, defibrillators, telemetry, temperature monitoring.
• 21,500 square feet of independent bioanalytical facility for small molecules, biotherapeutics, and gene therapy products.
• Biosafety level 2 (BSL 2) facility 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 or Infinity I or Infinity II UPLC front-ends, and Tomtec and Thermo Versette automated liquid handlers: Triple Quad 4000, Triple Quad 6500, Triple Quad 6500+.
• Agilent 7700/7800 ICP-mass spectrometers and Agilent 1200 HPLC front-ends, plus DigiPREP digestion equipment.
• VersaMax microplate readers, SpectraMax multi-mode plate reader, Meso Scale Discovery S 600 ECL’s, Gyrolab xPlore, BF-FACSCanto II, and Siemens BCS XP hemostasis analyzer.
• Gamma and beta counters, radio flow detector, LC-DAD/UV equipment, and oxidizer.
• LabVantage LIMS for reporting, data management, analytical run acceptance, sample/materials management, storage management, and equipment validations/ management.

Achievements

• 12 successful inspections and audits by the Dutch authority (IGJ) and the US FDA in the last 10 years.
• 150+ client audits with satisfactory outcomes between 2011 and 2019.
• Strong collaboration with leading medical centers in The Netherlands (e.g. VUMC, AMC, UMCG, Radboud, MCL, Isala Clinics, and Martini Hospital).

Accreditation

• GLP-compliant laboratory as of August 2000.
• GMP-compliant laboratory for pharmaceutical analysis as of October 2008.
• GMP-compliant pharmacy as of February 2005.
• GCP-compliant clinic and laboratory as from July 2005.

Experience in the Clinic

• Over 250 Phase I/II/BA/BE studies conducted since inception of the Clinic in 2004.
• Disease categories: CNS disorders and (c)CSF sampling, gynecology, infections, respiratory diseases and allergies, cardiovascular diseases, gastroenterology, metabolic diseases and diabetes, anesthesia, pain, inflammatory diseases, and ophthalmic diseases.
• Studies have involved >13,000 healthy subjects and >500 patients.
• Recruitment database of >22,000 potential study participants.
• Administration routes: PO, IV, IM, SC, nasal sprays, and oral inhalation.
• Sample types: plasma, whole blood, arterial blood sampling, urine, fecal samples, CSF-fluid (spinal taps as well as repetitive CSF)
• Imaging techniques: PET, MRI, fMRI

Experience in Bioanalysis

• Extensive validated bioanalysis 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 2,000 bioanalysis studies conducted and more than 1 million samples analyzed.
• 20+ years experience in development, implementation, and validation of quantitative LC-MS assays for small molecules, peptides, proteins, ADC’s oligonucleotides, and biomarkers, employing multiple bioanalytical platforms.
• 15+ years experience in development, implementation, and validation of ICP-MS assays for total-, free-, and trace elemental analyses, extended to LC-ICP-MS assays for speciation analysis, degradation/stability studies, or quantitation of parent compounds and metabolites.
• Proven expertise with integration of ICP-MS with other analytical platforms: ICP-MS and DAD/UV (diode array) for serial detection, and parallel detection by ICP-MS and LC-MS/MS, or ELISA-ICP-MS for the analysis of metallodrugs, metallic DNA fragments, and metallopeptides.
• 20+ years experience in development, implementation, validation of ligand-binding, hybridization, and enzymatic assays for the quantification of biotherapeutics and biomarkers in complex biological matrices.