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SERVICES

FNDR provides services for conducting preclinical studies for various bacterial, fungal and viral pathogens. A wide range of customisable assays are available for testing either as individual studies or comprehensive discovery programs. Please contact us for more details. 

TUBERCULOSIS

In vitro studies

  • MIC/MBC in wild type Mtb (replicating condition)

  • MIC in wild type Mtb (non-replicating condition(s) – nutrition starvation, low pH and stationary phase)

  • MIC in wild type Mtb in human plasma

  • MIC in wild type Mtb in combination with 1st line, 2nd line, new drugs and drugs in development 

  • MIC in drug resistant Mtb strains (SDR, MDR and XDR) 

  • Kill kinetics profile 

  • Cytotoxicity in THP-1 cells & Intracellular Efficacy in THP-1 Mtb infected Macrophages

  • Generation of resistant mutants (Mtb)

  • Biofilm Assay

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Animal Efficacy Models

  • Acute Model (Mice) 

  • Chronic Model (Mice or Guinea Pig)

  • Chronic Mouse Model (Combination with 1st line drugs) 

  • Infected Animal PK and Drug-drug Interaction studies

  • Drug resistant Mtb Chronic Mouse Model (Combination with 2nd line drugs)

  • Relapse Model (Mice)

  • Shortening of Treatment Duration model (Mice)​

Note: The Mtb infection in animal studies is performed through inhalation.

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Pharmacokinetics Studies​

  • Pharmacokinetics

    • LC-MS Method Development (fit for research) 

    • Uninfected Animals (blood and tissue distribution) 

    • Infected Animals (blood and tissue distribution) 

  • Compound estimation in macrophages (Intracellular efficacy assay) 

  • PK-PD and drug-drug interaction studies

    • Single Method for first line drugs (Isoniazid, Rifampicin, Ethambutol, Pyrazinamide) and Second line drugs (Clofazimine, Thioacetazone, Ethionamide, Moxifloxacin)

  • Bioanalysis of human TB patient samples for first- and second-line drugs

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NONTUBERCULOUS MYCOBACTERIA (NTM)

In vitro studies​

In vitro assays are available with the following NTM reference strains: 

  • Mycobacterium avium

  • Mycobacterium gordonae

  • Mycobacterium nonchromogenes

  • Mycobacterium kansasii

  • Mycobacterium abscessus

  • Mycobacterium fortuitum

  • Mycobacterium intracellulare

  • Mycobacterium smegmatis

  • Mycobacterium ulcerans

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Other Assays available: 

  • A panel of 60 Clinical isolates of drug sensitive and resistant NTMs (M avium, M abscessus, M intracellulare, M kansasii, M fortuitum)

  • Biofilm assay with M avium and M abscessus

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Animal Efficacy Models

  • Mice models with M avium and M abscessus are under development.

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BACTERIAL INFECTIONS

In vitro studies​

In vitro assays are available with the following strains:

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Gram positive bacteria panel

  • Staphylococcus aureus

  • Micrococcus luteus 

  • Bacillus subtilis 

  • Streptococcus pneumoniae

  • Enterococcus faecalis

  • Enterococcus faecium 

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Gram negative bacteria panel

  • Klebsiella pneumoniae

  • Acinetobacter baumanii

  • Pseudomonas aeruginosa

  • Enterobacter aerogenes

  • Enterobacter cloacae 

  • Salmonella typhimurium

  • Salmonella typhi

  • Proteus

  • Shigella

  • Escherichia coli 

  • Proteus vulgaris

  • Serratia marcescens

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 A diverse range of drug sensitive and drug resistant strains are available for testing. Please contact us for more details.

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Animal Efficacy Models

  • Neutropenic Septicemia mice model. 

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FUNGAL INFECTIONS

In vitro studies​

In vitro assays are available with the following strains:

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Fungal strains panel

  • Acremonium strictum

  • Actinomadura madurae

  • Aspergillus fumigatus

  • Aspergillus niger

  • Candida albicans

  • Candida auris

  • Candida glabrata

  • Candida tropicalis

  • Cryptococcus neoformans

  • Fusarium oxysporum

  • Nocardia asteroids

  • Rhizopus arrhizus

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 A diverse range of drug sensitive and drug resistant strains are available for testing. Please contact us for more details.

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Animal Efficacy Models

  • Systemic fungal infection model with C albicans is currently under development.

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COVID-19

In vitro studies

All assays are performed with SARS-CoV-2 USA-WA1/2020 (Wuhan-like). Other SARS-CoV-2 variants available for testing are Alpha, Beta, Gamma, Delta, Kappa, Scotland, Denmark and BatPav. 

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  • Cytopathic Effect (CPE) Assay in Vero E6 cells

    • Single Concentration or IC-50 generation

    • Modes available: Concomitant, Preincubation, Neutralization and Replication

    • All CPE assays include the initial cytotoxicity testing

  • Combination assays in Vero E6 cells

  • Antiviral assay in Calu3 cells 

  • PRNT Assay and MNT Assay 

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Animal Efficacy Models

Syrian Hamster Model with Wuhan or Delta variant. 

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  • Therapeutic or Prophylactic Treatment

  • Routes of administration possible are oral, buccal, IP, SC, IM, IN and IV

  • Tissue viral load estimation via TCID-50, PFU or qRT-PCR methods

  • Tissue sampling: Lungs, Nasal Turbinate, other organs as required

  • Nasal Swabs (virus quantification via qRT-PCR)

  • Infected animal PK

  • Histopathology of lungs

  • Combination studies with Remdesivir, Molnupiravir or Nirmatrelvir

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Vaccine Testing

Immunizations are performed in Syrian Hamsters. 

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  • Possible routes of administration of the vaccine include oral, intranasal, intramuscular and subcutaneous.

  • Long term immunization periods are possible.

  • The immune response is measured through - 

    • Cytokines and T cell response with FACS

    • Antibody titre estimation using IgG/IgM ELISA

    • Neutralizing antibody estimation using PRNT Assay (Wuhan, Alpha, Beta, Gamma, Delta, Kappa, Scotland, Denmark and BatPav) 

  • Viral challenge with either Wuhan-like strain or the Delta variant in the standard Syrian Hamster Model.​

    • Tissue viral load estimation via TCID-50, PFU or qRT-PCR methods

    • Tissue sampling: Lungs, Nasal Turbinate, other organs as required

    • Nasal Swabs (virus quantification via qRT-PCR)

    • Histopathology of lungs

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OTHER VIRUSES

In vitro studies 

In vitro assays are available with the following viruses 

  • Human respiratory syncytial virus

  • Influenza A (H1N1, H2N3, H5N1, H7N9) and Influenza B 

  • Dengue (DENV1, DENV2, DENV3, DENV4)

  • Chikungunya

  • Zika

  • West Nile virus 

  • Japanese Encephalitis Virus

  • Under development: Rabies

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Assays

  • Cytopathic Effect (CPE) Assay for IC-50 generation

  • Viral Load Reduction Assay (VLRA) 

  • Plaque Reduction Neutralization Test (PRNT) 

  • Microneutralization Assay (MNA)

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Animal Efficacy Models for Therapeutic and Vaccine Efficacy 

  • Influenza (H1N1) mice efficacy model

  • Chikungunya model (mice)

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VIRUCIDAL TESTING

Virucidal assays can be performed with the following viruses

  • SARS-CoV-2 (Wuhan, Alpha, Beta, Gamma, Delta, Kappa, Scotland, Denmark and BatPav) 

  • Human respiratory syncytial virus

  • Influenza A (H1N1, H2N3, H5N1, H7N9)

  • Rotavirus A

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Methods: ASTM E1052 (suspension) and ASTM E1053  (spray)

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