Oligonucleotide therapeutics has emerged as a promising class of treatments for a wide range of diseases, including genetic disorders, cancer, and viral infections. However, the stability of these oligonucleotides under varying environmental conditions remains a critical factor influencing their efficacy, safety, and overall therapeutic potential. Stability studies are essential for determining how oligonucleotides respond to different storage conditions, temperature fluctuations, and other stress factors that may occur during packaging, transportation, or long-term storage. These studies provide invaluable data that supports product development, regulatory submissions, and shelf-life determinations.
Alfa Chemistry is committed to providing clients with professional stability study services. Our team of experts utilizes advanced techniques and comprehensive testing protocols to deliver data that ensures your oligonucleotide therapeutics are safe, effective, and stable.
Factors Affecting Oligonucleotide Stability
There are many factors that affect the stability of oligonucleotides. Here, we mainly introduce the following two key factors.
- Temperature and Humidity Conditions
The stability of oligonucleotides is affected by temperature and humidity. High temperatures can accelerate degradation processes, leading to the breakdown of oligonucleotides that compromise the therapeutic efficacy. Similarly, changes in humidity can affect the hydration state of oligonucleotides, causing them to undergo physical changes that may alter their biological activity. Stability testing under accelerated conditions, which simulate high temperatures and high humidity, helps accelerate the chemical or physical changes of oligonucleotides, providing essential information for drug evaluation, packaging, transportation, and storage.
Exposure to light, especially ultraviolet (UV) radiation, can also degrade oligonucleotides by inducing photochemical reactions. UV light can cause the formation of pyrimidine dimers, leading to mutations or loss of function. Therefore, protecting oligonucleotides from light exposure during storage and transportation is essential. Stability testing must include light exposure conditions to assess potential photodegradation and establish protective measures for handling.
Our Capabilities
At Alfa Chemistry, we provide comprehensive stability study services tailored to meet the specific requirements of oligonucleotide therapeutics. Our state-of-the-art stability test chambers are designed to simulate a wide range of temperature and humidity conditions, allowing us to perform accelerated and long-term stability studies. We adhere to industry standards and regulatory guidelines, such as ICHQ1A, to ensure the robustness and reliability of our results. Our testing capabilities mainly include:
| Impact Factor Test | High Temperature Test (40°C) |
| High Humidity Test (75%±5%) |
| Strong Light Exposure Test (4500Lx±500Lx) |
| Accelerated Stability Test | 25±2°C, RH60±5%, 6 months |
| Long-Term Stability Test | -20°C, 24 months |
| 5±3°C, 24 months |
Why Choose Us
We understand that each oligonucleotide therapeutic is unique, and we provide customized stability testing plans that address the specific requirements of your product.
Our stability studies are designed to meet international regulatory standards, including ICHQ1A, ensuring that the data we provide is accepted by regulatory authorities worldwide.
- Expert Analysis and Reporting
Our team provides detailed, data-driven reports that help you understand the stability profile of your product and make informed decisions regarding packaging, storage, and shelf life.
Our products and services are for research use only and cannot be used for any clinical purposes.
