Stability Analysis for Nucleic Acid Drugs

Comprehensive stability analyses provide insight into the nature of nucleic acid drugs and ensure the reliability of their quality, efficacy, and safety throughout their lifecycle, which is critical to advancing the successful development of these innovative biologics. CD Formulation's stability testing staff is also available to design study protocols based on client project requirements. Our experienced method development and validation team can provide any other stability-related services required.

Why Analyze the Stability of Nucleic Acid Drugs?

Nucleic acid molecules contain easily broken phosphodiester bonds, which are susceptible to degradation by acids, bases, hydrolytic enzymes, etc. Nucleic acid molecules are also vulnerable to degradation by intracellular and extracellular enzymes. Simultaneously, they are readily hydrolyzed by nucleases inside and outside the cell, leading to the loss of biological activity. Moreover, the physicochemical properties of nucleic acids, such as solubility and viscosity, can be easily influenced by environmental factors like temperature and pH, potentially causing a decline in the performance of the formulations. Stability analysis, however, relies on a systematic study and comprehension of the preparation and its production process. It involves designing experiments to understand how the quality characteristics change over time under the influence of various environmental factors (such as temperature, humidity, light irradiation, etc.). This analysis provides supportive information and a scientific basis for formulating the drug's prescription, process, packaging, storage conditions, re-examination period/expiry date, and the establishment of quality standards.

Fig.1 Some factors affecting the stability of nucleic acid drugs. (CD Formulation)

Explore Our Nucleic Acid Stability Analysis Services

Nucleic acid drug stability analysis is crucial for designing suitable formulations and developing stability measures. The stability study is essential for production and marketing capabilities, as well as for promoting the application of drugs with low toxic side effects and high efficacy.

CD Formulation offers customers comprehensive stability study services that strictly adhere to the principles of formulation stability based on the product's usage environment, packaging, storage, and transportation.

The services we provide include the following.

Examination Pharmaceutical Formulations Items

Characteristics such as appearance, impurities (degradation products, etc.), moisture content, and other quality indicators should be established. Additionally, specific indicators reflecting the quality of the dosage form should be determined based on the dosage form's characteristics. For example, the dissolution rate of solid oral formulations, slow and controlled release formulations, enteric formulations, droplet distribution of inhalation formulations, and encapsulation rate and leakage rate of liposomes.

Our Workflow of Nucleic Acid Drugs Stability Analysis Services

Fig. 2 Workflow of nucleic acid drugs stability analysis. (CD Formulation)

Sample Preparation

Select and collect nucleic acid drug samples to be tested. Dispense samples into appropriate containers to ensure adequate sample volume for each test condition.

Set up conditions for testing, such as temperature, moderation, light, and time points.

Sample Storage and Monitoring

Regularly monitor and record parameters such as the actual temperature and humidity of the storage environment to ensure the accuracy of the test conditions.

Sampling and Testing

Samples are taken from different storage conditions at predetermined time points.

Tests are performed on the removed samples and typically include the following items:

• Appearance, color, solubility, etc.
• Degradation product analysis, content determination, purity analysis, etc.

Data Analysis

The results of the tests at each point in time and under each condition are recorded and organized. The data is then analyzed to assess the stability of the nucleic acid drug and to determine the rate of degradation and the major degradation pathways.

Stability Reporting

Prepare a stability test report, including test plan, test results, data analysis and conclusions.

Continuous Stability Monitoring

Continued stability monitoring is required at a later stage to ensure long-term stability, and stability monitoring reports are submitted to the regulatory agency on a regular basis.

Why Choose Us for Stability Analysis?

• Complete Instrument Resources
  Our company is equipped with first-class large-scale precision instruments, such as high-resolution mass spectrometry, GC-MS, LC-MS, ICP-MS, IC, NMR, etc., which offer various options for comprehensive product research.
• Deep Professional Accumulation
  Our analytical service platform possesses excellent technical research and development capabilities and has been dedicated to nucleic acid drug development, production, and research for numerous years. With extensive practical experience, we can offer customers more professional and tailored drug quality research solutions, which have significantly contributed to the research of numerous drugs.
• Perfect Quality Management System
  Our analytical service platform caters to a diverse range of customers to ensure the authenticity, integrity, reliability, and traceability of data and information, in compliance with regulatory standards.

Publication Data

CD Formulation is committed to supporting the scientific community and the biotechnology industry through our nucleic acid drug stability services. Our state-of-the-art facilities, experienced team, and comprehensive testing solutions make us the ideal partner to ensure the quality, stability, and efficacy of your nucleic acid products. Contact us today to discuss your project.

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.