ADME Services

ADME服务 | 毒性测试服务 | 康宁

Corning® GentestSM
Contract Research Services

ADME服务

Advance pre-clinical drug discovery goals with the support of Corning Gentest Contract Research Services and put your organization on a rapid path to sound decision-making.

Take your ADME/Tox testing to completion.

Founded in 1992, we stand ready to become an extension of your ADME team—or your virtual ADME partner—to help strengthen your ability to meet your drug discovery and pre-clinical goals.

  • Full range of ADME/Tox services: To support your comprehensive ADME/Tox testing requirements, we offer the following services. Don’t see what you’re looking for? We can provide customized assays to meet your particular in vitro ADME needs.
    • Enzyme induction and inhibition, including cytochrome P450 (CYP) induction services using both cryopreserved and fresh human hepatocytes; cytochrome P450 inhibition services with high quality data analysis; and UGT inhibition studies
    • Permeability and transport, including screening and step-wise approach to drug-drug interaction assays using Solute Carrier (SLC) over-expressing Corning TransportoCells™; ABC transporter services to support your efflux transporter assay needs; and permeability studies
    • Reaction phenotyping studies to help identify enzyme-mediated pathways of elimina­tion for a compound
    • Rapid in vitro metabolic stability testing using several different enzyme sources
    • Rapid in vitro plasma protein binding testing, offering both ultrafiltration and equilibrium dialysis methods to determine % drug bound to plasma proteins
  • Experience: For more than 20 years, the Corning Gentest Contract Research team has been developing and conducting in vitro drug-drug interaction studies to support hundreds of pharmaceutical discovery and development programs.
  • Skilled Study Directors: Our scientists are experts in the areas of drug absorption, transporters, metabolism, induction, toxicity, and industry/regulatory guidance. We'll work with you to facilitate informed decisions.
  • Alignment with Regulatory Guidance: Study designs are continually updated to be aligned with current Regulatory Agency guidance. So you can be assured you’ll have the right data for submission to the FDA/EMA.
  • Quality Data: You can depend on our team for accurate, reproducible data and regulatory submission-ready reports.
  • Custom assay services: Corning has expertise in adapt­ing clients’ protocols to facilitate comparison with in-house databases of results. Customizations can include the choice of extracel­lular matrix, treatment media, positive control-inducing chemical/concentration, and delivery solvent, as well as many other client-specified adaptations.

 

ADME Portfolio Now Part of Discovery Life Sciences

ADME Services

Corning Gentest Contract Research Services

Induction/Inhibition

Enzyme Induction and Inhibition

Enzyme Induction and Inhibition

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Most drug-drug interactions are metabolism based and tied to cytochrome (CYP) P450 enzymes, although UDP-glucuronosyl transferases (UGT) enzymes may also be involved. To help you identify better drugs faster, we offer complete in vitro CYP inhibition and induction tests, as well as testing for the inhibition of several UGT isoforms. Assays are conducted with Corning UltraPool™ HLM 150 pooled human liver microsomes, drug probe substrates, and validated LC/MS/MS analysis methods using stable-labeled isotope internal standards.

Most drug-drug interactions are metabolism based and tied to cytochrome (CYP) P450 enzymes, although UDP-glucuronosyl transferases (UGT) enzymes may also be involved. To help you identify better drugs faster, we offer complete in vitro CYP inhibition and induction tests, as well as testing for the inhibition of several UGT isoforms. Assays are conducted with Corning UltraPool™ HLM 150 pooled human liver microsomes, drug probe substrates, and validated LC/MS/MS analysis methods using stable-labeled isotope internal standards.

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Transport

CYP Induction

CYP Induction

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Services include evaluation of drug-transporter interactions using in vitro models expressing human and animal transporters from the ABC-binding cassette (ABC) and solute-linked carrier (SLC) superfamilies. We also offer the unique capability to study human P-gp-mediated drug transport using the cDNA transfected LLCPK 1 porcine cell line. For SLC transport studies, we use TransportoCells to assess if your test article is a substrate and/or inhibitor of uptake transporters in line with the latest regulatory guidance for develop­ment of new investigational drugs.

Services include evaluation of drug-transporter interactions using in vitro models expressing human and animal transporters from the ABC-binding cassette (ABC) and solute-linked carrier (SLC) superfamilies. We also offer the unique capability to study human P-gp-mediated drug transport using the cDNA transfected LLCPK 1 porcine cell line. For SLC transport studies, we use TransportoCells to assess if your test article is a substrate and/or inhibitor of uptake transporters in line with the latest regulatory guidance for develop­ment of new investigational drugs.

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Reaction Phenotyping

Reaction Phenotyping

Reaction Phenotyping

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Reaction phenotyping studies help identify enzyme-mediated pathways of elimina­tion for a compound—key information that affects population variability in metabolism and the risk of its becoming a victim drug in a drug-drug interaction event. Assays can be performed using Corning Supersomes™, human liver microsomes, chemical inhibitors, and/or immunoinhibitory antibodies. We can identify metabolic pathways catalyzed by multiple enzymes, including CYPs, FMOs, UGTs, CES enzymes, among others, to help identify if your compound could be the “victim” of drug-drug interactions.

Reaction phenotyping studies help identify enzyme-mediated pathways of elimina­tion for a compound—key information that affects population variability in metabolism and the risk of its becoming a victim drug in a drug-drug interaction event. Assays can be performed using Corning Supersomes™, human liver microsomes, chemical inhibitors, and/or immunoinhibitory antibodies. We can identify metabolic pathways catalyzed by multiple enzymes, including CYPs, FMOs, UGTs, CES enzymes, among others, to help identify if your compound could be the “victim” of drug-drug interactions.

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Metabolic Stability

Metabolic Stability

Metabolic Stability

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We offer rapid in vitro metabolic stability testing using several different enzyme sources. Most often, this test utilizes hepatocytes or liver microsomes. Corning’s metabolic stability testing, which uses hepatocytes, features carefully selected, single-freeze donor pools with results provided for human and pre-clinical species to maintain data consis­tency from assay to assay. The use of UltraPool HLM 150 microsomes ensures minimal inter-assay variability.

We offer rapid in vitro metabolic stability testing using several different enzyme sources. Most often, this test utilizes hepatocytes or liver microsomes. Corning’s metabolic stability testing, which uses hepatocytes, features carefully selected, single-freeze donor pools with results provided for human and pre-clinical species to maintain data consis­tency from assay to assay. The use of UltraPool HLM 150 microsomes ensures minimal inter-assay variability.

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Plasma Protein

Plasma Protein Binding

Plasma Protein Binding

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For high throughput drug discovery and development applications, we provide rapid in vitro plasma protein binding testing, offering both ultrafiltration and equilibrium dialysis methods to determine % drug bound to plasma proteins. Blood cell partitioning testing to determine the % drug associated with blood cells is also available.

For high throughput drug discovery and development applications, we provide rapid in vitro plasma protein binding testing, offering both ultrafiltration and equilibrium dialysis methods to determine % drug bound to plasma proteins. Blood cell partitioning testing to determine the % drug associated with blood cells is also available.

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What’s New

Featured Products, Resources, and More

Featured Products, Resources, and More

“Inside-Out” Membrane Vesicles: an In Vitro Model to Study Transporter-mediated Drug Interactions that can Lead to Liver Toxicity

This poster highlights data from an in vitro study, indicating that “inside-out” membrane vesicles are a quick and useful tool to screen MRP2, BSEP, and BCRP inhibitors that can potentially cause liver toxicity or DDI in vivo.

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Development of a Novel Transporter “Thaw and Go” Model to Study Regulatory Authority Recommended SLC Transporters

This poster showcases the development and validation of a new transporter “Thaw and Go” model for studying uptake clearance and drug-drug interaction with SLC transporters. The complete portfolio includes all of the regulatory authority (USFDA, EMA) and industry recommended SLC transporters.

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Characterization of a Novel Transporter Model for Studying Drug Interactions with Organic Anion-Transporting Polypeptide (OATP)

As shown in the previous poster, Corning developed a novel “Thaw and Go” model to help the pharmaceutical industry address regulatory recommendations in a fast and easy manner. This poster focuses on validating the model for evaluating drug interaction with OATP1B1 and OATP1B3.

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Development and Characterization of a Novel Cell-based Model to Study MATE1- and MATE2-K-mediated Drug Uptake and Interactions

The study demonstrates that Corning's “Thaw and Go” cell-based transporter model is a compliant and useful in vitro tool to screen MATE1 and MATE2-K involved in drug interaction and/or drug induced renal toxicity in the early stages of drug development.

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Corning® TransportoCells™

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Corning TransportoCells are high performance mammalian cells in a cryopreserved format that transiently overexpress a single human SLC transporter protein - thawed, plated, & assayed in just two days.

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