In Vitro ADME Services
In vitro ADME services can effectively provide evaluations of compounds’ absorption, distribution, metabolism, and drug interactions. These services aid in understanding the behavior of compounds within the human body, providing a critical basis for dosage setting, side effect predicting, and risk assessment during the development process.
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Overview
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Services
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Featured Strengths
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FAQs
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Related Resources
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Related Services
Overview
Our in vitro ADME team offers a very wide services in the field of Physicochemical Properties, Permeability, Metabolic Stability, Drug-Drug Interaction, Transporter, and Protein Binding and Partitioning. We also have a variety of advanced automated liquid workstations and LC-MS/MS analysis technologies to further improve the assays' speed, quality, and throughput. More new modalities with complex structures have emerged from the recent R&D pipelines, including Proteolysis-Targeting Chimeras (PROTACs*), oligonucleotides, and antibody-conjugated drugs (ADC). There are many challenges in the in vitro ADME study of these new modalities. We continuously expand the platforms to support the ADME studies of these new modalities.
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Services
Typically, in the Lead Finding (LF) stage, compounds' solubility, lipophilicity, permeability, and microsomal stability are determined first. The obtained data are used to build the structure-property relationship of compounds, screen chemical structure categories, and confirm the priority of multiple structural backbones. At the Lead Optimization (LO) and Pre-Clinical Candidate (PCC) stages, comprehensive in vitro ADME studies are usually required. These include multi-species metabolic stability, plasma protein binding, transporters-related drug interaction, and inhibition of the drug-metabolizing enzymes combined with animal PK data to predict human PK performance. In the Investigational New Drug (IND) stage, a comprehensive evaluation of in vitro ADME properties is required and conducted per the requirements of drug registration authorities. It should be noted that the in vitro ADME screening study is usually not designed for regulatory submission purpose.
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Physicochemical Property
Solubility (KS, TS), pKa, logD, logP, and PSA
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Permeability
PAMPA, Caco-2, MDCK I, MDR1-MDCK I, MDCK II, and MDR1-MDCK II
Ex vivo Franz cell-based dermal penetration assay
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Whole Blood/Plasma Distribution and Protein Binding
B/P ratio
Dialysis, ultracentrifugation, ultrafiltration, flux dialysis, competition dialysis, etc
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Drug-drug Interaction
Metabolism-mediated drug interactions
Transporter-mediated drug interactions
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Metabolism
Matrix stability (Tissue, plasma, SGF/SIF, buffer, whole blood, GSH reaction, etc.）
Metabolic stability (Microsomes, S9, hepatocytes, cytosol, lysosome, mitochondria, recombinase, etc.）
Featured Strengths
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High-throughput and comprehensive service types
We can provide various services from screening to IND application, with more than 100 types of assays and one-stop service to the clients. Multiple automation can ensure continuous improvement of throughput.
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Fast data delivery
Based on solid technology, optimized operation, and improved throughput, we can save time and cost for the clients. For most screening assays, no more than 5 working days are needed from compound receipt to report submission.
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High-quality data
The application of automation can reduce human errors and improve data quality. A complete set of in vitro ADME evaluation services can be provided to meet the submission requirements from the FDA, EMA, and NMPA for new drugs. Currently, the IND applications of hundreds of drug candidates have been completed, and all of them have passed the on-site audit by the regulatory authority.
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Experienced researchers
The core team has more than 15 years of ADME research experience, which can provide the most effective data in the shortest time, save resources, and accelerate the development process.
FAQs
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What is In Vitro ADME test?
In vitro comes from the Latin term "in glass”. It refers to studies that are performed outside of a living organism in a controlled environment, such as a test tube or petri dish. In vitro studies are often contrasted with in vivo ("within the living") studies, which are done in a whole living organism.
The in vitro testing is ideal for testing a potential drug compound with well-controlled testing conditions at an early stage. In vitro testing requires less resources and tends to be much quicker than in vivo models. In vitro testing helps drug developers understand if the drug candidate is suitable to move forward with further investigations.
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What does In Vitro ADME test study?
In vitro ADME studies absorption (A), distribution (D), metabolism (M), and excretion (E) properties of the drug candidates in a panel of assays outside of a living organism. The deions of each keyword are as follows.
Absorption: Describes the compound’s ability to pass through physiological barriers such as the intestines, skin, etc.
Distribution: Describes how the compound is distributed throughout the body or tissue once it has been taken into the body.
Metabolism: Describes how the body breaks down the compound in organs such as liver, kidney, skin or the gut.
Excretion: Describes how the body removes the compound.
Our platform can also provide drug-drug interaction evaluation.
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