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ADME – Toxicity

In 2024, MarinBio successfully passed the FDA inspection with no 483s and no observations.

With 30 years of expertise, we specialize in delivering in vitro and cell based assays, including GLP/GMP, that are critical for preclinical and clinical studies. Our ADEM/Tox services offer:

  • Unmatched quality
  • Prompt timeliness
  • Cost-effective solutions
  • Exceptional communication


MarinBio assists you throughout the drug development process, including IND/BLA applications, and commercialization.

We maintain direct interactions with the FDA, both independently and through our clients.

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ADME-Tox assays are used in pharmacology during drug discovery and development to evaluate drug candidates for Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADME-Tox).

These assays study the rate a drug enters and leaves the body and its potential toxic effects due to metabolites.

Key Components of ADME-Tox Assays

  • Absorption: Measures the rate a drug is absorbed into the bloodstream from the site of administration.
  • Distribution: Assesses how the drug spreads throughout the body and reaches various tissues.
  • Metabolism: Evaluates how the drug is metabolized or broken down, primarily by liver enzymes such as cytochrome P450.
  • Excretion: Determines how the drug and its metabolites are eliminated from the body, typically through urine or feces.
  • Toxicity: Tests for potential toxic effects of the drug on cells and tissues, including cytotoxicity, genotoxicity, and organ-specific toxicity.
Tox Assays
  • Cell Viability and Cytotoxicity Assays:
    Assess the toxic effects of compounds on cell health and survival.
  • hERG Assay (Fluorescence):
    The hERG assay is used to evaluate the potential of a compound to block the human ether-a-go-go-related gene (hERG) potassium channel, thereby assessing the risk of cardiac arrhythmias and ensuring regulatory compliance in drug development.
  • Glutathione (GSH) Assay:
    Changes in glutathione (GSH) levels are crucial for assessing toxicological response and serve as indicators of oxidative stress, which can potentially lead to apoptosis or cell death.

Cell-Based & In Vitro ADME / Tox Assays We Offer

ADME Assays
  • CYP450 Enzyme Inhibition Assays:
    Measure the impact of compounds on cytochrome P450 enzyme activity, which is crucial for drug metabolism.
  • Monoamine oxidase (MOA) Assay:
    Monoamine oxidases (MAO-A and MAO-B) are enzymes that play a significant role in the metabolism of neurotransmitters such as dopamine, serotonin, and norepinephrine. Understanding how a small molecule drug interacts with these enzymes is crucial for predicting its metabolism, potential drug interactions, and overall pharmacokinetics.
  • Plasma Stability Assays:
    Assess the stability of peptides, DNA, and RNA (siRNA) drugs in plasma to predict in vivo half-life.
  • In Vitro Permeability Assays (Vascular or endothelial):
    In vitro permeability assays are laboratory tests designed to evaluate the ability of drug compounds to pass through biological membranes.
  • P-glycoprotein (Pgp) Assay:
    P-glycoprotein (Pgp) assays are specialized in vitro tests designed to evaluate the interaction of drug compounds with the P-glycoprotein transporter, a critical membrane protein involved in drug transport and metabolism.
  • UDP-glucuronosyltransferase (UGT) assay:
    UDP-glucuronosyltransferase (UGT) assays are in vitro tests used to evaluate the interaction of drug compounds with UGT enzymes, which play a crucial role in the metabolism and detoxification of many endogenous and exogenous substances.
  • Plasma Protein Binding Assays:
    Evaluate the binding of peptides, DNA, and RNA (siRNA) drugs to plasma proteins.

Questions about Our Cell Based Assay Services?​

Contact us to discuss the specifics of your project. Our team of experienced scientists is ready to assist you with tailored solutions to meet your unique needs. Whether you need help with assay development, FDA IND, stability study,  lot release approval, or other scientific endeavors, we are here to support you.
Contact us to learn more about our cell based assay services

We will initiate your project as soon as the proposal is approved and signed by you. Our streamlined process ensures a quick start, minimizing delays and maximizing efficiency. Fill out the form below to email us or click our live chat option to speak with a MarinBio Scientist and get your project underway.

Yes, we have over 30 years of expertise in developing and validating cell based assays for FDA IND, lot release or stability study approval. Our team can also liaise directly with the FDA on your behalf, ensuring a smooth and compliant process. Please contact us to learn more about how we can assist you with your assay development and FDA approval needs.

MarinBio scientists are experienced and creative in designing, developing, validating assays. Some of the assays we perform are listed below, but there are many more that we created, developed and validated. Give us call so that we may help you.

MarinBio scientists conducting targeted protein degradation assays in advanced laboratory

Need help or have questions on cell based assays?

Give us a call at 415-883-8000

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