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Bioanalytical & ADME Assays and Services List

In vitro ADME, LC/MS-MS bioanalysis & metabolite identification service list

Q2 Solutions provides services designed to help you get the data you need and to drive informed development decisions for your pharmaceutical product. Our integrated drug metabolism solutions include high-throughput screening assays, human clearance predictions, drug-drug interaction risk assessments and metabolite profiling to support clinical safety. In addition to the services listed below, we can also provide bundled services for discovery and regulatory-phase packages to enable decision-making in early discovery through IND and beyond.

Bioanalytical/Pharmacokinetics Services
Discovery Phase Bioanalysis by LC-MS/MS Details
Tiered bioanalysis service available Levels 0 – 3 (all non-regulated)
Bioanalytical with optional Pharmacokinetic Analysis: Plasma, Tissues Species selectable, non-compartmental analysis
Bioanalytical with optional Pharmacokinetic Analysis: Dried Blood Spot Species selectable, non-compartmental analysis

In Vitro ADME Services
High-Throughput Screening Assays Details
Solubility/Permeability Assays:  
    Solubility: Turbidimetric
10 μM to 100 μM in buffer
    Permeability: MDCK
MDCK (wild type), MDCK-II cell lines
    Permeability: PAMPA
Pre-coated PAMPA plate system
Metabolic Stability Assays:  
    Metabolic Stability: Single Point
Hepatocytes or microsomes; Species selectable
    Metabolic Stability: Intrinsic Clearance
Hepatocytes or microsome; Species selectable
    Metabolic Stability: Plasma or S9
Species selectable
Inhibition Assays (enzyme):  
    P450 Inhibition: Reversible Single Point
Single concentration, P450 selectable (up to seven)
    P450 Inhibition: Reversible IC50
Multiple concentrations, P450 selectable (up to seven)
    Time Dependent P450 Inhibition: Single Point
Single concentration, CYP3A
    Time Dependent P450 Inhibition: Multiple Point
CYP3A, CYP2B6, CYP2C8, CYP2C9, CYP2C19
    Time Dependent P450 Inhibition: IC50 Shift
CYP3A or CYP3A4, 2D6 and 2C9 cocktail assays
Inhibition Assays (transporter):  
    Transporter Inhibition: Bile Salt Export Pump (BSEP) Inhibition
Vesicles
Reaction Phenotyping Assays:  
    P450 Reaction Phenotyping: Substrate Depletion
Microsomes with inhibitors for CYP2C9, CYP2D6, CYP3A
Other Assays:  
    Protein Binding: Plasma, Microsomes, Brain Homogenate, HSA, AAG
Equilibrium dialysis HTDialysis or RED devise; Species selectable
    Blood to Plasma Ratio
Species Selectable
Bundled Tier 1 Screening Assays:  
    Metabolic stability, permeability, CYP inhibition
Human liver microsomes, MDCK, CYPs 2C9, 2D6, 3A in cocktail
Late Stage Discovery to Regulatory Phase Assays Details
Metabolic Stability Assays:  
    Metabolic Stability: Intrinsic Clearance
Hepatocytes and microsomes; Species selectable (±ABT optional)
    Metabolic Stability: Glucuronidation (UGT) Clearance
Microsomes (liver, intestine, kidney); Species selectable (±BSA)
    Metabolic Stability: Low Turnover Drugs
Hepatocyte coculture systems (HµREL); Species selectable
Inhibition Assays (enzyme):  
    P450 Inhibition: Hepatocytes Suspended in Plasma
CYP2C9, CYP2D6, CYP3A; combined reversible and TDI inhibition model
    P450 Inhibition: Reversible IC50
Definitive IC50 for up to 7 P450s/8 assays
    P450 Inhibition: Reversible Ki
Definitive Ki for selected P450s
    Time Dependent P450 Inhibition: IC50 Shift
IC50 shift following 30 min pre-incubation (part of reversible inhibition IC50 assay)
    Time Dependent P450 Inhibition: Kinetics
CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A; kinact / KI and CLinact
    Time Dependent P450 Inhibition: Mechanism
Metabolic intermediate (MI) complex formation, CYP3A4
    UGT Inhibition: Reversible IC50
UGT1A1, 1A3, 1A4, 1A6, 1A9, 2B7; Definitive IC50 using human liver microsomes
Induction Assays:  
    P450 Induction: mRNA discovery screen in human hepatocytes
CYP1A2, CYP2B6, CYP3A4 message RNA assay following 24 hour treatment
    P450 Induction: mRNA in 3 human hepatocyte donors with Relative Induction Score
CYP3A4, CYP2B6, CYP1A2, CYP2C8, CYP2C9, CYP2C19 mRNA, 48 or 72 hour treatment with basic DDI modeling (± CYP activity evaluation)
Reaction Phenotyping Assays:  
    Hepatocytes with pan-CYP inhibitor (ABT)
Estimate CYP vs. non-CYP mediated fraction of metabolism
    P450 Reaction Phenotyping: Substrate Depletion
Combination of rCYPs to predict HLM fm,CYP using RAF and/or chemical inhibitors
    P450 Reaction Phenotyping: Metabolite Formation
Combination of rCYPs and/or chemical inhibitors
    Estimation of Fraction Metabolized by CYP3A4 and CYP3A5
    Aldehyde Oxidase (AO) Reaction Phenotyping: Human
Combination of rCYPs and/or chemical inhibitors (ketoconazole and CYP3cide)
Human cytosol or hepatocytes ±Hydralazine (AO inhibitor)
Other Assays:  
    Protein Binding: Equilibrium Dialysis by HTDialysis Method
Plasma, microsomes, HSA, AAG; Species selectable; human clinical plasma
    Blood to Plasma Ratio
Human
Bundled IND-Enabling Assays:  
    In Vitro DDI: CYP inhibition, time-dependent inhibition (TDI) and induction
HLMs and human hepatocytes; Assays meet regulatory guidelines for IND

Metabolite Profiling and Identification Discovery Services
Discovery to Regulatory Phase Assays Details (Waters Synapt G2-S and Thermo OrbiTrap and Q-Exactive HRMS)
Metabolite Profiling and Identification: Microsomes and Hepatocytes Species selectable; S9, cytosol, or hepatocyte coculture systems available
P450 Reaction Phenotyping: Metabolite Formation Microsomes with inhibitors for CYP1A2, CYP2C9, CYP2D6, CYP3A
Metabolite Profiling and Identification: In Vivo Services Plasma, urine, bile, feces, and/or tissue homogenate; Species selectable
Metabolite Profiling and Identification: Exploratory Profiling Exploratory assessment using unlabeled drug; Preclinical or clinical samples
Metabolite Profiling and Identification: Radioprofiling and MetID Preclinical or clinical samples; Typically plasma, urine, bile, and/or feces
Reactive Intermediate Screen: Glutathione or Cyanide Trapping Agent Microsomes; Species selectable
Reactive Intermediate Screen: Covalent Binding Radiolabel covalent binding in microsomes or hepatocytes, species selectable


A full range of bioanalytical and ADME services

Q2 Solutions operates one of the world’s largest and most respected bioanalytical and ADME laboratory networks. From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies in North America, South America, Europe and Asia. Our highly trained scientists utilize a range of leading-edge technology, automation and state-of-the-art techniques.
  • In Vitro ADME Assays and Metabolite Identification Services in support of rapid drug discovery ADME property optimization and regulatory filings
  • Bioanalytical Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) services for the quantitative determination of small molecule drugs and macromolecule therapeutics in support of pharmacokinetic (PK) studies
  • Immunoassay Services for Enzyme-Linked ImmunoSorbant Assays (ELISA), mesoscale (MSD), electrochemiluminescence (ECL), and neutralizing antibody assays (NAB) in support of PK and immunogenicity studies
  • Biomarker Services for LC/MS and ligand-binding assays for the quantitative determination of bioanalytical biomarkers

To learn more about any of our Bioanalytical and ADME services, please visit our BioA/ADME Services page.