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Pharmacokinetics (PK) Assays for Nucleic Acid Drugs

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CD Formulation, as your drug discovery partner, can improve the safety and efficacy of your drugs by developing and establishing reliable methods for analyzing and evaluating biological activity and providing early guidance for clinical studies. We are committed to providing you with high-quality, reliable pharmacokinetics (PK) assays to help you succeed in your drug development process.

About Pharmacokinetics Assays for Nucleic Acid Drugs

Pharmacokinetics (PK) is a critical part of the drug development life cycle. Before a drug can enter the clinic, its effectiveness and safety need to be demonstrated in animals to meet regulatory requirements. Therefore, it is essential to study the pharmacokinetics of the drug as well as to carry out immunogenicity risk assays at the IND stage and clinical phase I.

PK analysis can provide a dynamic picture of nucleic acid drugs in vivo. By measuring the changes in concentration of drugs and their metabolites in biological samples such as blood and tissues, we can calculate key PK parameters such as half-life, absorption rate, and volume of distribution of the drug. These PK data are critical for determining the appropriate dose and route of administration. In addition, PK analysis can help us understand the metabolism of nucleic acid drugs in the body. Identifying and quantifying the formation of metabolites helps us to assess the safety of the drug, as some metabolites may be potentially toxic.

Fig.1 Application of pharmacokinetics in nucleic acid therapeutics. Fig.1 Pharmacokinetics in clinical application of nucleic acid therapeutics. (Herkt M, et al., 2021)

Explore Our Nucleic Acid Pharmacokinetics Assays Services

CD Formulation specializes in preclinical PK analysis, focusing on in vivo PK assessment early in drug discovery. Our PK studies provide in-depth data on PK parameters, organ distribution, and more, which are critical for evaluating nucleic acid drugs and a prerequisite for interpreting preclinical efficacy and toxicology results. Our pharmacokinetics assays include the following.

Items	Descriptions
Physicochemical Property Analysis	Our services include testing the physicochemical properties of materials and developing effective dosing and sampling strategies to ensure that meaningful and accurate data is obtained. We have the ability to handle a variety of routes of administration, including intravenous, oral, and subcutaneous, as well as continuous administration for short-term and long-term infusions, utilizing continuous microsampling and parallel sampling techniques for comprehensive PK data analysis.
PK Parameter Analysis and Modeling	We can generate comprehensive concentration versus time profiles, which allows us to provide a complete PK parameter profile, which is essential for advancing drug development programs. We are committed to providing accurate in vivo PK profiles for your molecules to advance your drug discovery efforts.
Biological Sample Collection and Analysis	To support PK studies at all stages of development, we develop, validate, and perform nucleic acid formulation assays using ELISA and Meso Scale Discovery (MSD) assays. In addition, we utilize our analytical platforms to perform PK assays with extremely high sensitivity, which is critical to the success of dose-escalation studies.

Our Advanced Pharmacokinetics Assays Platform for Nucleic Acids

We help you select the best platform for your program based on nucleic acid dosage form, required sensitivity and regulatory guidance. We have extensive experience in developing and validating assays to assess PK behavior at all stages using the following platforms.

Flow cytometry for RO Assays Platform

Detects binding occupancy of targeted receptors using flow cytometry
Enables assessment of nucleic acid drug binding to targets in vivo
Provides critical data for PK/PD linkage establishment

ELISA Platform

Immunoassay technique based on antigen-antibody reaction
Quantifies the concentration of nucleic acid drugs and their metabolites in biological samples
High sensitivity and specificity for a wide range of PK samples

ddPCR Platform

Highly accurate quantitative analysis of nucleic acids based on digital PCR technology
Accurate determination of trace levels of nucleic acids, including intact drug and degradation products
Used in PK studies to support the quantification of ultra-low concentrations of drugs

MSD Platform

Multi-analytical platform based on electrochemiluminescence technology
Simultaneous quantification of multiple nucleic acids and their metabolites
High sensitivity and low sample consumption for PK sample analysis

qPCR Platform

Used to detect trace drug concentrations and target gene expression levels
Plays an important role in PK/PD linkage building

Our Workflow for Nucleic Acid Pharmacokinetics Assays

Fig.2 Workflow of nucleic acid PK analysis. Fig.2 Flow chart of nucleic acid pharmacokinetics assays. (CD Formulation)

Experimental Design

Based on the project requirements and research objectives, we have developed a scientifically sound pharmacokinetics study protocol.

Method Validation

Prior to the commencement of the study, we will perform a systematic validation of the analytical method. This process will involve evaluating the method's precision, accuracy, linear range, detection limit, and quantification limit.

Sample Analysis

Biological samples will be collected at various stages of the experiment, following the established sampling time points. These samples will be processed and analyzed using validated analytical techniques.

PK Analysis

Upon completion of the sample analysis, we will use the obtained data to plot a concentration-time curve. PK parameters, such as maximum blood concentration (C_max) and time to peak (T_max), will be calculated using various methods.

Report Writing

Experimental data and results will be compiled and analyzed into a comprehensive PK analysis report. This report will include the experimental design, method validation results, sample analysis data, and calculations of PK parameters.

Why Choose Us for Nucleic Acid Pharmacokinetics Assays?

With years of experience in nucleic acid PK research, we have built up an experienced and professional analytical team. The team members have profound theoretical background and rich practical experience, and are capable of performing all kinds of nucleic acid PK analysis projects.
Our company has a complete platform covering ELISA, ddPCR, MSD and other advanced analytical techniques.
We have established a comprehensive quality control and quality assurance system to ensure that every step of the analytical data meets the strict quality standards.

Publication Data

Technology: PK analysis by GalNAc technology in combination with siRNA drugs

Journal: International Journal of Molecular Sciences

IF: 4.9

Published: 2023

Results:

RNA-mediated drugs are a rapidly growing class of therapies. Over the past five years, the list of FDA-approved RNA therapeutics has expanded due to their unique targets and long-term pharmacologic effects. Their absorption, distribution, metabolism, and excretion (ADME) have important clinical implications, but their pharmacokinetics properties are not fully understood. Most RNA therapeutic drugs are structurally modified to prevent rapid excretion from the plasma and are efficiently distributed to target organs by intravenous or subcutaneous injection (with few exceptions). The distribution of drugs in tissues depends on the addition of molecules that can be translocated to the target site, and RNA therapeutics show low distribution volumes because of their molecular size and negatively charged backbones. Nucleases metabolize RNA therapeutics into short chains, but at relatively low rates. As a result, most RNA therapeutics are excreted in the intact form. This review covers not only the ADME properties of RNA therapeutics, but also clinical pharmacological data on RNA therapeutics, such as drug-drug interactions or population pharmacokinetics analyses.

Fig.3 Pharmacokinetics analysis of RNA therapy. Fig. 3 Pharmacokinetics parameters of the RNA therapeutics. (Jo S J, et al., 2023)

As a professional service provider in the field of nucleic acid drug PK analysis, CD Formulation has many years of rich experience in the industry. We have established a professional and stable analytical team, and mastered a complete platform covering ELISA, ddPCR, MSD and other advanced analytical techniques. Contact us, we can provide you with professional solutions to help you in drug development.

References

Herkt M, Thum T. Pharmacokinetics and proceedings in clinical application of nucleic acid therapeutics. Mol. Ther. 2021, 29(2): 521-539.
Jo S J, Chae S U, Lee C B, et al. Clinical pharmacokinetics of approved RNA therapeutics. Int. J. Mol. Sci. 2023, 24(1): 746.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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