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Nucleic Acid Drugs Immunogenicity Testing

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Immunogenicity is an inherent property of a drug, and assessing the immunogenicity of biotechnology drugs is crucial because the resulting antibody response can significantly impact the accurate evaluation of drug toxicity. As a company focused on nucleic acid pharmaceuticals, CD Formulation possesses substantial experience in conducting immunogenicity tests. Our team comprises seasoned immunologists, clinical trial specialists, and data analysts with extensive expertise in evaluating the immunogenicity of nucleic acid drugs.

About Immunogenicity Testing of Nucleic Acid Drugs

For the development of new generation nucleic acid drugs, chemical modifications are commonly used to improve stability, safety, cellular uptake, and efficacy. However, these modifications may also increase immunogenicity. Therefore, analyzing the immunogenicity of nucleic acid drugs is necessary. In this process, positive control antibodies play a crucial role as key reagents. The specificity and potency of these antibodies directly impact the speed, accuracy, and reliability of the analytical method. Nevertheless, due to the relatively uniform structure and low immunogenicity of nucleic acid drugs, it is often challenging to produce high-quality positive antibodies by directly immunizing animals with them as antigens. The current standard practice involves conjugating nucleic acid drugs with carrier proteins, followed by animal immunization and antibody preparation.

Fig.1 Analyzing and collecting immunogenicity samples. Fig.1 Immunogenicity sample collection and analysis. (Henry S P, et al., 2022)

Explore Our Nucleic Acid Drugs Immunogenicity Testing Services

Considering that immunogenicity is highly correlated with drug efficacy and safety, analyzing the immunogenicity of nucleic acid drugs is essential to support nucleic acid drugs development and clinical trials. With state-of-the-art testing equipment and extensive methodological expertise, CD Formulation can offer you professional and dependable immunogenicity evaluation services. Our services include:

Total anti-drug antibody (ADA) analysis

We utilize ELISA, MSD, and other highly sensitive assays to comprehensively evaluate drug-induced ADA subtypes such as IgG, IgM, IgA, and IgE. We dynamically monitor changes in ADA levels to provide essential data for drug safety assessment.

Neutralizing Antibody (NAb) Analysis

We have developed a ligand binding assay to accurately assess whether ADA has neutralizing activity and to analyze the potential impact of ADA on target binding in conjunction with the specific mechanism of action of the drug. This provides a basis for predicting clinical efficacy.

Pre-existing Antibody Analysis

We detect the presence of antibodies that cross-react with the drug before administration and assess the potential impact of pre-existing antibodies on pharmacokinetics (PK) and efficacy of the drug to help guide the design of clinical trials.

Customized Testing

We develop customized immunogenicity testing solutions, including cross-reactivity and immune complex analysis, tailored to specific drug and clinical requirements. This ensures you receive comprehensive and reliable data support.

Our Technology Platforms for Nucleic Acid Drugs Immunogenicity Testing

We have developed a rapid, accurate, and reliable bioanalytical platform for nucleic acid drugs immunogenicity testing. Our platform is distinguished by its high sensitivity, wide effective linear range, homogeneity, high reproducibility, low matrix effect, good stability, and high throughput.

Platform	Descriptions
ELISA	Enzyme-Linked Immunosorbent Assay (ELISA) is one of the most commonly used antibody detection methods. It utilizes enzyme-labeled antigen or antibody to bind specifically to a sample and quantitatively analyzes the level of antibody in the sample by detecting the enzyme activity. ELISA is simple, easy to perform, and offers high sensitivity, making it suitable for analyzing large quantities of samples. We have extensive experience in developing and optimizing ELISA methods and can create high-performance detection systems for various types of ADA.
ECL	Electrochemiluminescence (ECL) technology utilizes chemiluminescence signals generated by electrochemical reactions for immunoassays. Compared to ELISA, the ECL method has higher sensitivity and dynamic range, and can more accurately detect low concentrations of ADA.
RIA	RIA (Radioimmunoassay) uses radioisotope labeling of antigens or antibodies to analyze ADA. It is highly sensitive and can accurately quantify trace amounts of ADA.
SPR	Surface Plasmon Resonance (SPR) is a real-time kinetic assay for protein-drug interactions, used for qualitative and quasi-quantitative analysis of the binding ability of ADA to drug targets. SPR does not require labeling and can directly reflect the interaction between ADA and drugs, providing valuable information for evaluating ADA neutralization activity.

Our Workflow for Nucleic Acid Drugs Immunogenicity Testing

Fig.2 Immunogenicity testing flow chart for nucleic acid drugs. Fig.2 Flow chart of nucleic acid drugs immunogenicity testing. (CD Formulation)

Project Design

We will collaborate with you to understand your specific requirements, including analytical objectives, sample types, and detection targets.

Method Development

Our expert team will select the appropriate platform and develop a customized assay tailored to your specific needs.

Sample Analysis

A skilled team of laboratory technicians will conduct sample analyses while strictly adhering to standard operating procedures.

Data Analysis

Our data analysis specialists will interpret the results and provide comprehensive reports.

Why Choose Us for Nucleic Acid Drugs Immunogenicity Testing?

We have advanced immunoassay platforms such as ELISA, ECL, RIA, SPR, etc., which enable us to choose the most appropriate assay based on specific requirements.
We have accumulated rich experience in method development and optimization to ensure high sensitivity and specificity of the test results.
Our analytical team comprises experts in the fields of immunology, bioanalysis, and clinical trials, with extensive experience in immunogenicity assessment.
From experimental design, sample processing, to data analysis, we offer comprehensive tracking and optimization services to guarantee the efficiency and smoothness of the analysis process.
We have a well-established laboratory management system and efficient project execution capabilities, which enable us to complete sample analysis and provide results in a timely manner.

Publication Data

Technology: Immunogenicity assays for drug

Journal: BioDrugs

IF: 5.313

Published: 2016

Results:

Biopharmaceuticals have the potential to elicit immunogenic responses in those receiving treatment, which may affect the efficacy and safety of these drugs. Therefore, immunogenicity must be assessed at all stages of clinical development of biopharmaceuticals, including post-market surveillance. Although regulators require rigorous assessment of the immunogenicity of biopharmaceuticals, there is a lack of uniform standards for the type, quantity, and quality of evidence, as well as a lack of guidance on experimental design of immunogenicity assays or standards for comparing immunogenicity of biopharmaceuticals. Here, the authors review the factors associated with immunogenicity of biopharmaceuticals, potential clinical implications, and current regulatory guidance for assessing immunogenicity, and discuss methods for assessing immunogenicity in nonclinical and clinical studies.

Fig.3 Immunogenicity assays for drug Fig.3 Immunogenicity assays for biopharmaceuticals and assessment. (Pineda C, et al., 2016)

CD Formulation can develop high-performance ADA assays tailored to various project requirements and choose suitable technology platforms to offer comprehensive and reliable support for immunogenicity analysis. Please do not hesitate to contact us for more information.

References

Henry S P, Arfvidsson C, Arrington J, et al. Assessment of the immunogenicity potential for oligonucleotide-based drugs. Nucleic Acid Ther. 2022, 32(5): 369-377.
Pineda C, Castañeda Hernández G, Jacobs I A, et al. Assessing the immunogenicity of biopharmaceuticals. BioDrugs. 2016, 30: 195-206.

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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