Comprehensive DMPK Services: Industry-Leading Bioanalytical Solutions

Crown Bioscience provides industry-leading Drug Metabolism and Pharmacokinetics (DMPK) and Absorption, Distribution, Metabolism, and Excretion (ADME) services designed to streamline your drug discovery and drug development process. The results from DMPK/ADME studies early in the drug discovery process will allow you to determine compound efficacy, drug interactions, and toxicology assessments, among many other findings. Our comprehensive in vitro and in vivo solutions deliver accurate, reliable data to help you make informed decisions and achieve regulatory success early so you can move from preclinical studies to clinical trials with confidence.

Stages of DMPK from Early Drug Discovery to FDA Filing

DMPK analysis is crucial at every step in the drug discovery process, from in vitro to in vivo. Our DMPK/ADME offerings have a proven success rate assisting clients starting with early drug discovery.

Available DMPK and ADME Services

Our non-GLP DMPK services are available as an integrated drug discovery platform or a standalone service, and include cutting-edge LC-MS/MS and HPLC technologies alongside ELISA-based and MSD assays.

In Vitro ADME Services

Physicochemical property (solubility and stability)
Matrix stability (plasma/serum/WB, tissue, and buffer)
Plasma protein binding (Distribution)
Metabolic stability (Liver microsomes, S9, hepatocytes)
Caco-2 permeability and transporter
Red blood cell distribution

In Vivo DMPK Services

Full animal FK: Mouse, Rat, *Dog, *NHP
Administration Routes: IV, PO, SC, IM, IP. IT etc.
Dose Strategies: Single, multiple and cassette dosing
Serial blood microsampling
Tissue distribution
Pre-formulation screening
PK/PD
MTD & Tolerability
WinNonlin for PK parameters (Half-life, AUC, Cmax, Vd, etc)

Bioanalysis

Large molecule

Immunoassays method development and validation
Proteins, antibodies, ADCs, and peptide drugs
Immunogenicity test(ADA)

Small molecule and NCE

Method development & validation in various biological samples
Compounds, PROTACs, Oligo, Amino acids, etc

ADC

Total antibody(Tab), ADC, Conjugated payload, Free payload
DAR(Drug to Antibody Ratio)

Toxicology Services

In Vivo tox (single, repeat, dose escalation studies
Toxicokinetics (TK)
Humanized genetically modified mouse models for target-specific biologics toxicity (mAb, BiTE)
Histopathology
Hematology: CBC, blood chemistry
Urinalysis
Immune-phenotyping (FACS/IHC)
Cytokine (inflammatory biomarkers)
Immunogenicity (ADA)
Tissue cross reactivity (TCR)
ADC/Payload toxicity

Choose Crown Bioscience for your drug discovery DMPK/ADME studies

Crown Bioscience is the premier Contract Research Organization (CRO) choice for DMPK/ADME studies for many reasons. Our comprehensive services enable rapid evaluation of pharmaceutical and safety properties, facilitating the selection of robust drug formulations and optimization of drug discovery and preclinical development strategies. Combined with our team’s scientific expertise, agility, and preparedness, your project will be successful throughout the drug discovery process.

Comprehensive DMPK Services

We offer a wide array of in vivo pharmacokinetic (PK) services for both small and large molecules. Services include:

In Vivo PK Studies: Utilizing various species and administration routes.
Bioanalysis: Eploying advanced technologies such as LC-MS/MS and HPLC, alongside ELISA-based and MSD assays, for accurate quantitation of parent compounds and metabolites.
Additional Services: Including method development and validation, dosing solution analysis, tissue distribution studies, excretion assays, and maximum tolerated dose (MTD) determination.

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DMPK Capabilities and Services

In vivo PK of small and large molecules

Samples from various species (mouse, rat, rabbit, dog, NHP, pig, human)
Various administration routes (i.v., p.o., i.p., s.c., i.m.)
In vivo PK study design
Single, multiple, and cassette dosing PK
In vivo crossover studies for bioavalibility (F)
Plasma protein binding
Histology and pathology expertise and sample preparation
Serial blood collection over 24 hours
PK tissue distribution and mass balance
Excretion assays
Maximum tolerated dose (MTD)

Bioanalysis

Method development and validation
Quantitation analysis (parent compound, metabolites)
Dosing solution analysis
Various biological sample analysis (blood, plasma, bile, urine, feces, tumor tissue, etc.)

Our Analytical Equipment

Expertise and Quality Assurance

With a team of experienced scientists and extensive in vivo expertise, Crown Bioscience ensures high-quality data through rigorous quality assurance systems. Our global presence, with biomarker and bioanalysis laboratories across North America, Europe, and Asia, allows us to customize services to meet specific research and drug development needs.

Integrated Solutions

Beyond DMPK services, Crown Bioscience provides a broad spectrum of integrated solutions, including preclinical research services, translational platforms, and clinical trial support. This integration allows for seamless progression from early drug discovery through to clinical development.

Studies Completed

This data point indicates the total number of studies in Q2 2023 that the CSAT, Customer Effort, and Customer Expectation scores are measured against.

Customer Satisfaction

Also known as CSAT, this metric indicates how satisfied customers are with the complete Crown Bioscience customer experience.

Customer Effort

The Customer Effort Score (CES) is a metric that measures how easy it was to work with Crown Bioscience.

Our Customers Love Us

We are proud to boast the best Customer Experience in the Industry, explore our data below.

Monthly Customer Satisfaction Report

FAQs

What is DMPK and what is ADME?

DMPK (Drug Metabolism and Pharmacokinetics) and ADME (Absorption, Distribution, Metabolism, and Excretion) are closely related concepts in pharmacology and drug development, but they differ in scope and focus. DMPK refers to the study of how a drug is metabolized (broken down) and how it moves through the body (pharmacokinetics).

ADME (Absorption, Distribution, Metabolism, and Excretion) describes the four core processes a drug undergoes in the body:

Absorption: How a drug enters the bloodstream (e.g., through the gut or skin).
Distribution: How the drug spreads to tissues and organs.
Metabolism: How the drug is chemically altered, primarily in the liver.
Excretion: How the drug and its metabolites are eliminated from the body (e.g., urine, feces).

How do DMPK and ADME differ?

DMPK involves designing experiments and models to predict and optimize a drug's pharmacokinetics and metabolism. It helps determine dosing, drug formulation, and safety profiles.

ADME forms the foundation of understanding drug behavior but doesn't typically include the broader kinetic modeling or systemic interactions studied in DMPK. DMPK and ADME studies are performed throughout the drug development process. In vitro studies are often used to screen a large number of compounds, while in vivo studies are often performed later in development. In vivo studies can help identify areas of concern, such as low absorption or high clearance.

Why are DMPK/ADME studies important?

DMPK/ADME studies are critical in drug development as they provide insights into how a drug behaves in the body. These studies ensure that the drug reaches its intended target at the right concentration, has minimal side effects, and is effectively cleared from the system. By understanding these properties, researchers can optimize drug efficacy, safety, and dosing regimens, reducing the risk of late-stage failures in clinical trials.

Why choose Crown Bioscience DMPKT service?

We provide a one-stop and innovative DMPKT service for small molecule, therapeutic antibody, ADC as well as novel drug modalities from early discovery to IND submission during drug development.

As a comprehensive DMPK service provider, we established extensive capabilities which are including:

In vitro ADME/In vivo PK/Bioanalytical science/ADC and new modalities DMPK/Toxicity
Competitive throughput, TAT and price for service offering

By leveraging our current core platforms/expertise (PDX, PDO, in vitro, biomarker), we offer integrated solutions for pharmacokinetics and pharmacodynamic to support preclinical pharmacology research.

What PK/PD capability can Crown Bioscience offer？

Dose-response relationship: The effects of a substance at varying doses is analyzed against the desired pharmacological response, evaluating the optimal dose range, in turn determining if the drug achieves the required therapeutic outcome.
Effective dosage range: PK/PD studies will aid in identifying the therapeutic range of the drug or substance, contributing to the optimization of dosing regiments, and lowering the risk of adverse effects.
Identifying Biomarkers: Specific biomarkers will be identified, indicating the efficacy and safety of the substance, these biomarkers can be used to monitor responses during clinical trials, streamline the development of drugs, and personalize treatment approaches.
Interactions between substances: The pharmacodynamic interactions between the target drug and other substances can be assessed, allowing the development of drug combination strategies, along with predicting potential adverse effects, and optimizing therapeutic regimens.
Predictive modelling: Development of predictive models that will simulate the drug’s effect in different scenarios, helping forecast drug responses, optimizing dosing strategies, and informing decisions throughout the development process and clinical trial design.

Does Crown offer ADC DMPK and Tox service? If yes, what assays will be conducted for ADC PK in early discovery and preclinical stage?

Yes. Crown provides integrated solution for ADC DMPK and Tox evaluation. Below are general assays for ADC PK/PD and safety assessment based on guideline and white papers.

In vitro stability: Plasma/Serum/Whole blood, Lysosome, Liver S9/ liver homogenate, 2D/3D cell line
Bioanalysis and DAR characterization: intact and subunit of ADC, DAR stability and distribution link to efficacy and safety, payload release metabolites (if necessary)
Full animal PK: rodent and non-rodent PK
PK/PD: PK/PD and MOA in CDX/PDX model, Biodistribution
Tox: exploratory toxicity and TK

Does Crown provide exploratory tox service for different therapeutics?

Yes. Crown has general animal tox capability along with strong biomarker and bioanalysis investigations. Potential specialties services to include in vitro, organoid and HuGEMM platforms.

Can you provide DMPK service for new drug IND submission?

Yes. We provide PK service for IND enabling. This includes:

Drug PK screening (Hit-to-Lead, Lead Optimization)
Regular animal PK (single dose or repeat dose)
Comprehensive Efficacy and PK/PD in pharmacological models

At what stage in drug discovery do you conduct DMPK/ADME study?

DMPK/ADME studies are conducted throughout the drug discovery and development process, with specific focus and objectives at different stages:

Early Discovery (Lead Optimization): Initial ADME screening is performed to assess the drug-like properties of lead compounds. This includes solubility, permeability, metabolic stability, and potential drug-drug interactions to select the best candidates for further development.
Preclinical Development: More detailed DMPK studies are conducted in vitro and in vivo to evaluate pharmacokinetics (PK), bioavailability, and toxicity. These studies help refine dosing strategies and predict human outcomes.
Clinical Development: During clinical trials, DMPK studies continue to assess PK and metabolism in humans, validate dose adjustments, and monitor drug-drug interactions.

By conducting DMPK/ADME studies at each stage, researchers can identify potential issues early, optimize lead compounds, and improve the likelihood of clinical success.

What are the key assays used in ADME/DMPK studies?

Common assays include solubility testing, permeability studies (e.g., Caco-2), metabolic stability and enzyme inhibition assays, plasma protein binding studies, bioavailability assessments, and pharmacokinetic profiling.

How do ADME properties affect drug efficacy and safety?

Good ADME properties ensure a drug reaches its target site at the right concentration without accumulating to toxic levels or causing adverse effects. Poor ADME properties can result in low efficacy, high toxicity, or unpredictable behavior in the body.

How are in vitro and in vivo ADME studies different?

In vitro studies use controlled environments like cell cultures or enzymes to predict a drug’s behavior, while in vivo studies involve animal or human models to observe the actual effects in a living system.

What role does DMPK play in pharmacokinetics?

DMPK provides a framework for understanding the absorption, distribution, metabolism, and excretion of drugs, which directly impacts pharmacokinetics. This helps determine optimal dosing and frequency to achieve desired therapeutic outcomes.

How can poor ADME properties lead to drug failure?

Poor ADME properties can lead to inadequate bioavailability, rapid clearance, toxic accumulation, or failure to reach the target site. These issues often result in inefficacy or unacceptable side effects, causing drug candidates to fail in preclinical or clinical stages.

DMPK Services