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Purity Analysis for Nucleic Acid Drugs

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CD Formulation offers comprehensive nucleic acid drug purity analysis services. Our analytical process is designed to ensure the highest purity and quality of nucleic acid products. By utilizing advanced technologies and an experienced team, we can accurately assess the purity of nucleic acid samples and provide detailed data reports to support your product development and quality control needs.

Why Perform Nucleic Acid Purity Analysis?

DNA and RNA are integral to multiple fields, including gene therapy, bio-probing, and diagnostic methods. For example, they are employed to insert DNA into immune cells, enabling genetic modifications that allow these cells to express chimeric antigen receptor proteins, essential for cell-based immunotherapeutic applications. Solid-phase synthesis and similar techniques used to create nucleic acids can introduce small amounts of impurities at various synthesis stages. Therefore, thorough purity analysis and detection of nucleic acids is vital to ensuring that their quality, effectiveness, precision, safety, and biological activity are maintained consistently during production and research.

Fig.1 Diagram illustrating the process of nucleic acid drug analysis. Fig.1 Schematic diagram of nucleic acid drug analysis. (CD Formulation)

Methods of Nucleic Acid Purity Analysis

Methods	Descriptions	Advantages
UV Absorbance Technology	Utilizes a UV spectrophotometer equipped with a UV lamp and UV-transparent cuvettes to measure nucleic acid absorbance at 260nm, enabling the estimation of DNA concentrations.	User-friendly and employs standard laboratory apparatus. Cost-effective, eliminating the necessity for intricate or pricey reagents. Delivers prompt DNA concentration estimations. Accommodates a wide array of sample concentrations, generally maintaining a linear spectrum between 0.1 and 1.0.
Fluorometric Technology	A fluorometer and DNA-binding fluorescent dyes are used to deduce concentration from a standard curve, requiring the appropriate selection of excitation and emission wavelengths based on the specific fluorescent dye used.	Exceeds the absorbance method in sensitivity, particularly adept at identifying low-concentration samples. Provides enhanced accuracy through DNA-binding dye application compared to the spectrophotometric technique. Advanced fluorometric equipment can autonomously create standard curves, minimizing human computation errors.
Agarose Gel Electrophoresis Technology	The process involves using horizontal gel electrophoresis devices, agarose gel, and appropriate buffer solutions to separate DNA fragments by size with an electric field, allowing for the approximation of their concentration and size.	Facilitates the estimation of DNA concentration and size simultaneously. Aids in evaluating sample purity and structural integrity. Distinguishes DNA from coexisting impurities like RNA and proteins.

Explore Our Nucleic Acid Purity Analysis Services

Our service for analyzing the purity of nucleic acid drugs focuses on delivering precise testing and evaluation to maintain quality control throughout the development and manufacturing phases of nucleic acid-based products. We leverage cutting-edge technology and equipment, along with expert methods in nucleic acid molecular analysis, to perform thorough purity assessments. This service includes comprehensive support covering everything from preparation of samples to the analysis of data, ensuring accurate and dependable results. Our specialized team tailors solutions to meet the distinct needs of each client, guaranteeing that the purity of nucleic acid drugs aligns with both industry standards and specific client expectations.

During the process of purity analysis, we strictly comply with applicable standards and guidelines, utilizing multiple analytical methods to ensure the accuracy and consistency of data. The service extends to providing detailed reports, enabling clients to thoroughly understand the purity of their nucleic acid samples. This service is designed for nucleic acid drug initiatives of different scales and types, with the aim of offering solid quality assurance through meticulous scientific evaluation at every stage of a client's research and production process. All procedures are executed in laboratories that adhere to high standards, ensuring the integrity of the samples and the fairness of the testing process.

Our Workflow of Nucleic Acid Purity Analysis Services

Fig.2 Flowchart depicting the steps for nucleic acid purity analysis. Fig.2 Flow chart of nucleic acid purity analysis. (CD Formulation)

Preparation of Samples

Acquire samples of nucleic acid drugs and appropriately process them, which may include concentration, dilution, or other necessary pretreatment steps to prepare them for analysis.

Chromatographic Isolation

Employ HPLC to isolate the various components within the sample. This process involves selecting appropriate chromatography columns and mobile phases to enhance the effectiveness of separation.

Detection and Quantification

Select an appropriate detector, such as a UV detector, to analyze the separated nucleic acid components. Measure the peak areas or heights to conduct a quantitative analysis of the purity of the nucleic acids.

Data Analysis

Process the raw data from the detection phase, compute the percentage purity of the nucleic acids, and compare the results to reference standards to ensure the accuracy of the data.

Validation of Results

Confirm the results through repeated experimentation and the application of additional analytical methods, such as mass spectrometry, to ensure the reliability and reproducibility of the findings.

Our Technology Platforms

Platforms	Descriptions
HPLC Technology Platform	Employed in assessing nucleic acid drug purity, concentration, and degradation byproducts. This technique is capable of efficiently separating and quantifying intricate mixtures of nucleic acid molecules.
MS Technology Platform	Applied for accurately measuring the molecular weight, sequencing nucleic acids, and recognizing any modifications within nucleic acid drugs. Mass spectrometry is instrumental in ensuring the quality control of these drugs.
NMR Technology Platform	Used to elucidate the 3D structure and molecular conformation of nucleic acid drugs, particularly when exploring how these nucleic acids interact with their specific targets.
qPCR Technology Platform	Utilized for quantitatively examining the potency and transcriptional impacts of nucleic acid drugs, especially in experimental studies focusing on evaluating gene expression level variations.

Our Advantages of Nucleic Acid Purity Analysis Services

Extensive Instrumentation Resources
Equipped with specialized instruments for small nucleic acids, such as bio-liquid-phase UPLC, two-dimensional liquid chromatography-mass spectrometry, high-resolution mass spectrometry, and dedicated analysis software, alongside other specialized analytical instruments like ICP-MS, GC, and NMR, to meet the quality control and analytical needs of small nucleic acid drugs.
Deep Professional Expertise
Possessing comprehensive professional technical experience in the full suite of analytical processes, from raw material quality control to synthesis process and release of small nucleic acid products, offering quality control methods to support the development of small nucleic acid drugs.
Efficient, High-Quality, and Cost-Effective
Providing quality analysis services from raw materials to finished products of small nucleic acids, supported by a professional QC, QA, and technical team to efficiently meet diverse client needs.
Robust Quality Management System
With experienced small nucleic acid analysts and advanced analytical instrumentation, coupled with a comprehensive quality management system, ensuring the authenticity, completeness, reliability, and traceability of data and records, in compliance with regulatory requirements.

Publication Data

Technology: Nucleic acid purity analysis by electrophoresis technology

Journal: Frontiers in medicine

IF: 3.02

Published: 2019

Results:

Biobanking, the practice of collecting and storing human tissues for research, necessitates stringent quality control to ensure material integrity. Pre-analytical factors, like sampling methods, greatly affect result accuracy and reproducibility. Ensuring high-quality nucleic acids is essential for genetic analysis, requiring validation of how samples are collected and stored. Quality control procedures should evaluate both molecular and protein integrity to support genomic and proteomic analyses. Programs like IBBL's Proficiency Testing aim to uphold high standards in analyzing DNA, RNA, and tissue histology, essential for obtaining reliable research outcomes.

Fig.3 Assessment of RNA purity and integrity using 260/280 OD Ratio and RIN scores. Fig.3 RNA purity and integrity score attribution based on 260/280 OD Ratio and RIN. (Craciun L, et al., 2019)

For more information about our nucleic acid drug analysis services or to obtain personalized solutions, please feel free to contact us. We look forward to providing you with professional support and assistance.

References

Craciun L, Spinette S A, Rassy M, et al. Tumor banks: a quality control scheme proposal. Front. med. 2019, 6: 225.

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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