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ELISA Technology Platform for Nucleic Acid Drugs

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Enzyme-linked immunosorbent assay (ELISA) is a widely utilized immunoassay technology known for its high sensitivity, rapid detection, and accurate results. CD Formulation specializes in designing scientific experimental protocols, developing highly efficient assays, and conducting comprehensive methodological validation tailored to the specific needs of clients. We offer one-stop services for ELISA method development, method validation, method transfer, and kit development for biopharmaceutical research and development (R&D) clients.

Types of Our ELISA Platforms

Fig.1 Types of our ELISA platforms Fig.1 Types of ELISA Platforms. (CD Formulation)

Platforms	Descriptions
Direct ELISA Platform	In a direct ELISA, the target antigen is directly adsorbed onto a microplate and subsequently detected using enzyme-labeled antibodies.
Indirect ELISA Platform	The antigen is adsorbed onto a microplate and initially detected using an unlabeled primary antibody. This is followed by the detection of the primary antibody with an enzyme-labeled secondary antibody.
Sandwich ELISA Platform	The target antigen is situated between two antibodies. The solid-phase antibody captures the target antigen, which is then detected by an enzyme-labeled detection antibody.
Competitive ELISA Platform	The target antigen in the sample competes with an enzyme-labeled known antigen for binding to a solid-phase antibody. The amount of target antigen is then reverse-quantified based on the quantity that is bound.

ELISA Technology Platform Detection Methods

Colorimetric Assay

The colorimetric method utilizes the colored product generated by the enzyme acting on the substrate to measure absorbance using a spectrophotometer. This method is straightforward and user-friendly, and the results are easily interpretable.

Fluorescence Method Assay

The fluorescence method employs fluorescent markers to detect signals using a fluorescence scanner. Its primary advantage is its high sensitivity, enabling the detection of very low concentrations of the target molecule.

Chemiluminescence Assay

The chemiluminescence method relies on an enzyme-catalyzed luminescent reaction, with the resulting luminescence signal detected by a chemiluminescence detector. This method is highly sensitive and specific, making it suitable for detecting trace amounts of target molecules.

Operational Steps of ELISA in Nucleic Acid Formulations

Fig.2 Steps of ELISA in nucleic acid formulations Fig.2 Workflow of ELISA Technology. (CD Formulation)

Sample Processing

According to the specific requirements of the experiment, the nucleic acid preparation sample is appropriately diluted or treated.

Antigen or Antibody Coating

A specific antigen or antibody is encapsulated on a solid-phase carrier to form a solid-phase antigen or antibody.

Addition of Test Sample

The processed nucleic acid drug preparation sample is added to microtiter wells that have been coated with either an antigen or an antibody, allowing the target molecules in the sample to specifically cross-link with the solid-phase antigen or antibody.

Addition of Enzyme-labeled Antibody

Next, enzyme-labeled antibodies or antigens are added to bind with the target molecules in the sample being tested, resulting in the formation of an enzyme-labeled complex.

Washing

The microtiter plate is washed multiple times with a suitable washing solution to eliminate unbound impurities and interfering substances.

Color Development Reaction

A substrate is added, and the enzyme catalyzes the chromogenic reaction of the substrate, resulting in the formation of a colored product.

Result Determination

A spectrophotometer is utilized to measure the absorbance of the colored product. The results are then compared with the generated standard curve to calculate the concentration of antigen or antibody in the sample being tested, thereby completing the bioanalysis of nucleic acid pharmaceutical preparations.

Highlights of ELISA Technology Platform for Nucleic Acid Drugs

ELISA technology can detect trace amounts of target substances with high sensitivity and specificity, accurately distinguishing between the target substances and other components.
By utilizing a standard curve, the ELISA technique can accurately quantify the concentration of target substances in a sample.
ELISA technology is applicable for analyzing a wide range of biological components and can fulfill the detection requirements of various nucleic acid preparations.
Due to the standardization of ELISA kits and assay procedures, the results demonstrate high reproducibility and reliability.

Our Capabilities of ELISA Technology Platform for Nucleic Acid Drugs

CD Formulation offers a variety of ELISA analytical method development services, including method validation and method transfer, tailored to the specific testing purposes of our customers. These services encompass qualitative and quantitative analyses of biological activity, pharmacokinetics (PK) analysis, immunogenicity assays, and other requirements. We provide comprehensive support, from raw material reagents to sample testing.

Impurity Analysis for Nucleic Acid Drugs

ELISA can help detect nucleic acid-related impurities, such as incompletely purified nucleic acids or other protein contaminants, in the preparation. This ensures the purity and quality of the final product.

Stability Analysis for Nucleic Acid Drugs

The stability of nucleic acid formulations is monitored over time to evaluate their shelf life and usability under various conditions. Tests include the detection of nucleic acid degradation products and protein denaturation.

Nucleic Acid Drug Immunogenicity Testing

The ELISA technique is utilized to evaluate whether the nucleic acid drug elicits an immune response and to detect the production of antibodies against the drug.

Pharmacokinetics (PK) Assays for Nucleic Acid Drugs

ELISA monitors the absorption, distribution, metabolism, and excretion of drugs in the body, providing valuable data to support pharmacokinetic studies.

Publication Data

Technology: ELISA technology for antibodies

Journal: Sensors

IF: 3.4

Published: 2021

Results:

In this work, the authors describe the development of an automated microarray enzyme-linked immunosorbent assay (ELISA) that detects anti-SARS-CoV-2 antibodies in serum samples from COVID-19 patients and vaccinees. Analysis was performed using a microplate reader contrast color reaction. Comparing the results of the microchip automated ELISA with those of the microplate conventional ELISA, no statistically significant differences were found. In addition, the authors demonstrated that colorimetric reaction analysis can be performed with basic image analysis from photographs taken by a smartphone, which is a useful alternative in cases where specialized equipment or laboratory settings are not available.

Fig.3 ELISA technology for antibodies Fig.3 Assay's methodology and experimental setup. (González-González E, et al., 2021)

CD Formulation boasts a professional R&D team with extensive experience in developing analytical methods and experimental data for the bioanalytical detection of nucleic acid formulations. Our ELISA technology is suitable for all types of nucleic acid drug formulations, including DNA, RNA, and oligonucleotides, offering rapid and reliable bioanalytical solutions. Contact us, and we will customize an exclusive solution tailored to your project.

References

González-González E, Garcia-Ramirez R, Díaz-Armas G G, et al. Automated ELISA on-chip for the detection of anti-SARS-CoV-2 antibodies. Sensors. 2021, 21(20): 6785.

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STEP 3

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