DNA/RNA Drug Characterization Service

DNA/RNA Drug Characterization Service refers to a professional service that provides systematic analysis and characterization of DNA and RNA drugs, aiming to evaluate their molecular structure, chemical properties, physical attributes, and biological activity. With the widespread clinical development of nucleic acid drugs such as gene therapies, mRNA vaccines, siRNA, and antisense oligonucleotides (ASOs), ensuring the purity, integrity, stability, and efficacy of these innovative therapies has become a critical aspect of research and production. Through comprehensive characterization, researchers can accurately confirm the identity of drug molecules, detect potential impurities, optimize storage conditions and formulations, and provide scientific support for regulatory submissions, thereby ensuring the safety, effectiveness, and quality assurance of DNA/RNA drugs.

 



Liu L. et al. ChemistrySelect. 2021.

Figure 1. Various Types of Nucleic Acid Drugs.

 

Services at MtoZ Biolabs

Relying on multiple advanced analytical platforms, MtoZ Biolabs provides a comprehensive DNA/RNA Drug Characterization Service that spans from drug molecular identity confirmation to physicochemical property analysis, supporting both research and quality control needs.

 

DNA/RNA Drug Physicochemical Characterization Service

A systematic analysis of nucleic acid drugs’ physicochemical properties, covering key parameters such as molecular weight, acid dissociation constant (pKa), melting temperature (Tm), molar extinction coefficient, moisture content, and particle size and aggregation.

 

DNA/RNA Drug Quantification and Potency Determination Service

Provides accurate quantification and biological potency assessment of nucleic acid drugs, offering high-quality data support for drug development, formulation optimization, quality control, and regulatory submission.

 

DNA/RNA Drug Identification Service

Verifies whether the drug matches its designed sequence, identifies truncated fragments, modification differences, or exogenous contaminants, and detects potential impurities, ensuring drug authenticity and batch-to-batch consistency.

 

DNA/RNA Drug Structural Characterization Service

Systematically analyzes and confirms the sequence, secondary structure, and higher-order conformation of DNA/RNA drugs. Validates consistency with the designed sequence, detects potential modification loss, degradation products, and conformational changes, and provides scientifically reliable structural information.

 

DNA/RNA Drug Stability Analysis Service

Monitors and characterizes nucleic acid drugs under controlled conditions, including forced degradation studies, real-time stability assessments, and accelerated stability testing. Reveals stability profiles, potential impurity patterns, and changes in biological activity, providing reliable data for research, production, and regulatory submission.

 

DNA/RNA Drug Purity and Impurity Analysis Service

Purity analysis accurately evaluates the intact nucleic acid content in the drug formulation, while impurity analysis focuses on detecting truncated sequences, incomplete synthesis, chemical modifications, and degradation products.

 

Service Advantages

Advanced Analysis Platform: MtoZ Biolabs established an advanced DNA/RNA Drug Characterization Service platform, guaranteeing reliable, fast, and highly accurate analysis service.

 

Technical Diversity and Precision: Integrates multiple advanced analytical techniques, including mass spectrometry, chromatography, nuclear magnetic resonance, optical rotation, and differential scanning calorimetry, to achieve comprehensive and precise characterization from molecular weight and structure to physicochemical properties.

 

Customized Solutions: Offers personalized analytical plans tailored to different drug types and specific research needs.

 

Full Cycle Drug Development Support: Provides a complete characterization workflow covering molecular identification, purity and impurity analysis, structural elucidation, and stability and potency assessment, delivering critical data to support drug design, formulation optimization, and quality control.

 

Sample Submission Suggestions

Sample Types

Acceptable samples include purified DNA or RNA drug formulations, lyophilized powders, solution samples, and drug-containing buffer formulations. Samples should have sufficient concentration and quantity to meet the requirements of various analytical methods.

 

Storage and Transport

Samples are recommended to be stored at low temperature (-20℃ or below) and transported using a dry ice or liquid nitrogen cold chain, avoiding repeated freeze-thaw cycles.

 

It is recommended to contact the MtoZ Biolabs technical team prior to sample submission to obtain detailed and tailored guidelines for sample preparation and submission.

 

Applications

Drug Development and Optimization

Applied to the design and formulation optimization of DNA and RNA drugs, using structural, purity, and stability analyses to guide molecular modifications and the development of delivery systems.

 

Quality Control and Regulatory Compliance

Used for batch-to-batch consistency testing, impurity and degradation product identification, ensuring drugs meet pharmacopeial and regulatory standards, and providing reliable data for regulatory submissions.

 

Stability Studies

Supports optimization of storage conditions and formulation improvements, predicting degradation pathways and shelf life during storage, transport, and use.

 

Drug Dosage and Potency Assessment

Through quantitative analysis and potency testing, provides scientific guidance for clinical dosing and therapeutic regimen design.

 

FAQ

Q1: What Types of DNA/RNA Drugs Are Suitable for the DNA/RNA Drug Characterization Service?

A1: MtoZ Biolabs’ service covers a wide range of nucleic acid drugs, including antisense oligonucleotides (ASO), mRNA, siRNA, miRNA, and aptamers. We select the most appropriate analytical approach based on the drug type to ensure comprehensive applicability.

 

Q2: What Impurities and Degradation Products Can Be Detected?

The service can identify chemical and enzymatic degradation products, including truncated sequences, oxidation products, and phosphorylated isomers, providing critical data for drug safety assessment and stability optimization.

 

Deliverables

1. Comprehensive Experimental Details

2. Materials, Instruments, and Methods

3. Total Ion Chromatogram & Quality Control Assessment (project-dependent)

4. Data Analysis, Preprocessing, and Estimation (project-dependent)

5. Raw Data Files