Over 90% of All In Vitro ADME Capabilities Under One Roof

Charles River Laboratories' two facilities in Hungary, Budapest and Szeged, are fully equipped to solve virtually all of your in vitro ADME questions. The company is trusted by over 1,000 companies since its foundation in 1999 as SOLVO biotechnology, and has rapidly become well known for its drug transporter services and products. Through the years, related capabilities and technologies have been developed, allowing us to serve you today with the most comprehensive selection of in vitro ADME services, estimated to house > 90% of all in vitro ADME capabilities at CRL. Our services that may help you address your testing needs include drug metabolism, drug transport, and custom cell line and assay development. We follow the latest trends in pharmaceutical drug development and sciences, allowing us to provide ample expert solutions for you and all our other clients.

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Laboratories and Facilities

  • Budapest facility, opened in 2018: 9,710 square feet
  • Szeged facility, opened in 2020: 14,150 square feet
  • Transporter service laboratories
  • Drug metabolism laboratories
  • Bioanalytical laboratories
  • 3D cell culturing and NAM assays
  • In-house reagent production
  • Quality assurance unit

Staff

  • 142 employees
  • 34 with PhD or PharmD
  • 75 ADME scientists
  • 4 Senior Study Directors
  • 8 Study Directors

Service Areas and Study Types

  • Regulatory drug–drug interaction (DDI) services (ICH-M12 compliant, including current FDA, EMA, and PMDA guidance)
  • Efflux transporter services
    • MDR1 (P-gp), BCRP, and BSEP
    • More than 20 other human or preclinical species efflux transporters
    • Vesicular Transport Assays
    • MDCKII Monolayer Assays
    • LLC-PK1 Monolayer Assays
    • Caco-2 Permeability
    • ATPase Assays
  • Uptake transporter assays
    • OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, and MATE2-K
    • More than 60 other human or preclinical species uptake transporters
  • Drug metabolism services
    • Metabolic stability & MetID: Including relay method or HepatoPac for low turnover compounds
    • Enzyme Phenotyping
    • CYP450 inhibition
      • CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5
      • In hepatocytes and HLM, various methods (pooled or separate incubations), direct and time-dependent inhibition (TDI), multiple species
    • CYP induction
      • CYP1A2, CYP2B6, CYP3A4, CYP2C8, CYP2C9, CTP2C19
      • Regulatory type, or discovery screening
    • UGT metabolism
      • UGT1A1, UGT1A3, UGT1A4, UGT1A6, UGT1A9, UGT2B7, and UGT2B15
      • Pooled HLM or recombinant enzymes
    • Other non-CYP metabolism
      • SULT1E1, FMO, CES1 and CES2 etc.
  • Fully validated BCS-based biowaiver assessment (ICH-M9 guidance)
    • BCS Caco-2 based permeability assay
    • BCS gastric fluid stability (SGF, FaSSIF & FeSSIF)
    • BCS solubility testing
    • Fully validated LC-MS method development
  • Organ-specific barrier models
    • Hepatocyte uptake
    • Sandwich-cultured hepatocyte assays (B-clear)
    • HepatoPac micropatterned co-culture models
    • Caco-2 and transporter-knockout Caco-2 models
    • Renal proximal tubule cell assays
    • Rat brain endothelial cell monolayer assays
  • In vitro ancillary assays
    • Aqueous solubility determination
    • Cell viability assessment
    • Non-specific binding assessment
    • Plasma Protein Binding (PPB): Including RED device or ultracentrifugation
    • Plasma stability assays (in at least 7 species)
    • Red Blood Cell (RBC) partitioning
    • Electrophoretic mobility shift assay (EMSA)
  • Other cell-based assays
    • Reactive metabolite identification (Covalent binding)
    • Lysosomal trapping
    • High content imaging applications for hepatotoxicity testing in hepatocytes, HepaRG, HepG2 and other cell lines
  • Analytical capabilities
    • Small molecule LC/MS-MS
    • Radio detection (3H and 14C), Liquid scintillation
    • Metal detection by ICP-MS
    • Peptide drug or oligonucleotide quantification via LC/MS-MS and other methods
    • LC/MS-MS quantification of transporter proteins
  • Cell culturing and molecular biology capabilities
    • Custom cell line and assay development
    • Gene silencing or knock-out experience
    • qPCR gene expression analysis
    • Transient or stable transfection
    • Cell banking and cryopreservation
    • Cell membrane preparation

Quality and Process Initiatives

  • ISO9001:2015 Quality Management System certified
  • Electronic Common Technical Document (eCTD) compliant reporting
  • Study documentation archive
  • On-site IT support and logistics team
  • Excellent inspection history

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