As Candidate

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    Drug Metabolism &
    Pharmacokinetics (DMPK) Preclinical Discovery

    TCGLS has more than 12 years of experience in providing DMPK and bioanalytical services to global pharmaceutical, biotech, and animal health companies, supporting their preclinical drug discovery programs. Our state-of-the-art DMPK facility is well equipped with multiple liquid handling & LC-MS systems, as well as an in-house breeding facility to maintain a regular supply of rodents.

    Our team of highly skilled and dedicated scientists has extensive experience in a broad spectrum of DMPK studies to add value to our customers’ discovery efforts, by providing reliable data in an economic and efficient manner. We offer flexible solutions by developing customized assays as and when required to rapidly adapt to the project needs.

    In Vitro ADME (small molecules, peptides, and macrolides)

    • Physicochemical screening: kinetic & thermodynamic solubility, LogD
    • Solubility in biorelevant media (FaSSIF, FeSSIF, SGF)
    • Chemical stability in the buffer and bio-relevant media
    • Absorption/Permeability: PAMPA, Caco-2, MDCK-II, MDCK-MDR1
    • Efflux transporter assay (Substrate/Inhibitor screens): P-gp, BCRP, BSEP, MRP2, MRP4
    • Uptake transporter assay (Substrate/Inhibitor screens): OATP1B1, OATP1B3
    • Hepatocytes uptake assay
    • Metabolic stability: S9, microsomes & hepatocytes
    • AO/UGT based metabolism
    • Drug-drug interaction: CYP inhibition (multiple CYPs)
    • Drug-drug interaction: CYP induction (CYP1A2, 2B6, 3A4)
    • Time-dependent drug-drug interaction (TDI)
    • Plasma stability
    • Plasma Protein Binding
    • Microsomal & hepatocellular binding
    • Brain tissue binding
    • Blood to plasma ratio
    • CYP450 reaction phenotyping ( Under development)

    In Vivo Pharmacokinetics (Rats/Mice)

    • Discovery formulation development
    • Bioavailability study
    • Drug Administration Routes: PO, IP, IV, IM, SC, ID, IT, etc.
    • Continuous infusion using mechanical or osmotic pumps
    • Single/Repeat dose administration
    • Both Discrete & Cassette (5-in-one) dosing format
    • Tissue distribution study
    • Urinary excretion study in metabolic cages
    • CNS penetration/restriction assessment with exposure analysis in both brain and CSF.
    • Non-compartmental pharmacokinetic analysis, WinNonLin

    In Vivo Toxicokinetics

    • Exposure evaluation along with cage side observation

    Discovery Bioanalytical Services

    • LC-MS assays on NCE/NPE for ADME, PK, PD, early TK and discovery biology screening
    • Early metabolite ID; profiling, structure elucidation/soft-spot ID, species comparison
    • LC-MS analysis for endogenous small molecule biomarkers
    • LC-MS assays for prodrug-drug/metabolite quantitation, liposomal drug analysis
    • Rapid TAT, either for studies conducted in-house or as a stand-alone service
    • Extensive experience in working with multiple biological matrices (plasma, DBS, CSF, urine, feces, and tissues – brain, liver, spleen, nerve, lung, muscle, skin, fat, etc.)
    • Flexible to perform studies using client-defined procedures and acceptance criteria
    • 5 dedicated LC-MS platforms

    List of state of the art equipment>>

    Recently, we have expanded our existing state of the art ADME lab having multiple liquid handling systems, plate readers, compound storage facility, precision balance etc. The Data Analysis Lab has also been expanded.