DNA/RNA Drug Identification Service

DNA/RNA Drug Identification Service refers to an analytical service that systematically confirms the molecular identity, sequence accuracy, purity, and integrity of nucleic acid drugs. This service verifies whether the drug matches the designed sequence, identifies truncated fragments, modification differences, or exogenous contaminants, and detects potential impurities, thereby ensuring drug authenticity and batch-to-batch consistency.

Compared with small molecule or protein drugs, DNA/RNA drugs are typically composed of short nucleotide sequences with complex molecular structures that are prone to degradation, truncation, modification loss, or sequence errors, all of which have a significant impact on drug stability and efficacy. Without rigorous identity confirmation, drugs may show unstable or lost efficacy, as well as potential safety risks and regulatory compliance issues. Therefore, DNA/RNA drug identification is an indispensable step throughout early drug development, preclinical research, product release, and regulatory submission.

Bian X. et al. ACS Nano. 2025.

Figure 1. Common nucleic acid drugs.

Services at MtoZ Biolabs

With advanced analytical platforms and extensive experience in nucleic acid drug analysis, MtoZ Biolabs provides DNA/RNA Drug Identification Service to comprehensively verify the authenticity, sequence accuracy, and purity consistency of nucleic acid drugs.

We combine multiple analytical techniques, including polymerase chain reaction, mass spectrometry (LC-MS/MS, MALDI-TOF), high-performance liquid chromatography (HPLC/UPLC), capillary electrophoresis (CE), nucleotide sequence analysis, nuclear magnetic resonance (NMR), and electrophoresis, to validate drug authenticity and purity from multiple dimensions. Through customized testing strategies, we can identify truncated fragments, sequence variations, modification losses, and potential impurities.

Our professional team has extensive expertise in nucleic acid drug characterization and quality control, enabling us to provide highly sensitive, accurate, and traceable identification data to support drug development, quality release, and regulatory submission.

Analysis Workflow

The general workflow of DNA/RNA Drug Identification Service is as follows:

1. Sample Preparation

Pretreat DNA/RNA drug samples to ensure sample integrity and suitability for analytical conditions.

2. Method Selection

Choose appropriate analytical techniques based on drug type, modification characteristics, and research requirements.

3. Sequence and Molecular Identity Confirmation

Apply techniques such as PCR or mass spectrometry to verify drug sequence and molecular weight.

4. Impurity and Contaminant Detection

Use electrophoresis or chromatography to identify potential impurities, truncated fragments, or exogenous contaminants.

5. Data Analysis and Report Generation

Integrate and analyze data from multiple platforms to confirm drug identity and deliver a detailed report.

Service Advantages

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

One-Time-Charge: Our pricing is transparent, no hidden fees or additional costs.

High-Data-Quality: Deep data coverage with strict data quality control. AI-powered bioinformatics platform integrates all DNA/RNA Drug Identification data, providing clients with a comprehensive data report.

Customized Solutions: Develop the optimal experimental workflow based on drug characteristics and client requirements.

Sample Submission Suggestions

Sample Types

Acceptable samples include DNA drugs, RNA drugs, siRNA, mRNA, aptamers, and other types of nucleic acid drugs.

Storage and Transportation

Recommended storage at -20°C or below, with shipment on dry ice during transportation.

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

Validation in Research and Development Stages: Confirm molecular identity and sequence accuracy during candidate drug screening and early development to ensure the correct research direction.

Quality Control and Release Testing: Ensure consistency across different production batches and prevent counterfeit or incorrect products from entering the market.

Stability and Safety Studies: Evaluate drug stability during storage, transportation, and formulation development.

Regulatory Submission and Approval: Provide identification data to support new drug registration and compliance filing.

FAQ

Q1: What Technical Methods Are Commonly Used in DNA/RNA Drug Identification Service?

A1: Common methods include PCR for sequence-specific confirmation, mass spectrometry (LC-MS/MS or MALDI-TOF) for molecular weight and modification detection, HPLC/UPLC for separation and impurity analysis, and nuclear magnetic resonance (NMR) for structural characterization. These methods can be applied in a complementary manner to comprehensively confirm drug identity from molecular weight and modifications to sequence level.

Q2: Can Detection Specificity Be Ensured in Complex Biological Samples?

A2: Yes. By combining high-resolution mass spectrometry with sequence-specific PCR, highly specific detection can be achieved in complex matrices such as plasma or tissue extracts, minimizing the risk of false positives or false negatives.