Stability Testing

Stability testing is a crucial component of biologics development, ensuring that drug substances and products maintain their intended quality and efficacy throughout their lifecycle. A well-defined study protocol, aligned with regulatory guidelines, is essential to generating reliable stability data.

Stability studies play a key role in pharmaceutical development by evaluating how environmental factors—such as temperature, humidity, and light—affect the integrity of biologics and biotechnological products. These studies help determine:

• The optimal shelf life and storage conditions
• Potential degradation pathways and mitigation strategies
• The robustness of a formulation under various conditions

By conducting comprehensive stability assessments, manufacturers ensure that their products remain safe and effective until their expiration date.

Adhering to regulatory standards, such as ICH Q5C, is essential for the successful submission of stability data to health authorities. These guidelines establish a framework for:

• Stability testing methodologies
• Data analysis and reporting
• Submission requirements for well-characterized proteins and polypeptides

Rodon Biologics provides a full range of ICH-compliant stability testing conditions to meet your project’s requirements. In addition, we offer custom analytical services, including the development of test methods and protocols to monitor product stability effectively.

A well-structured stability study ensures reliable and meaningful data. Key factors in study design include:

• Study objectives: Defining the specific stability parameters to assess
• Test matrix selection: Identifying the appropriate conditions and time points
• Analytical methods: Using validated techniques to monitor stability markers

Types of Stability Studies

We conduct a range of stability studies to provide a comprehensive evaluation of product integrity:

• Accelerated stability studies: Simulating long-term storage conditions in a shorter timeframe
• Long-term stability studies: Monitoring product stability over extended periods
• Forced degradation (stress testing): Identifying degradation products to support analytical method development

Starting stability testing early in development helps identify the most robust and stable formulation, ensuring that the product remains viable during manufacturing, storage, shipping, and use. Additionally, stress testing generates degradation by-products, forming the foundation for reliable analytical method development.

To ensure product quality throughout its lifecycle, stability testing must assess:

• Identity, purity, integrity, and potency
• Impact of environmental conditions on product performance
• Shelf-life and in-use stability

At Rodon Biologics, we offer real-time and accelerated stability studies based on a customized study plan, including defined storage conditions, sampling schedules, and testing methodologies.

Our Stability Testing Services Include:

• Stress testing (forced degradation studies) – Simulates extreme conditions to identify degradation pathways and assess product resilience, supporting analytical method development.
• Formulation stability testing – Evaluates how different formulations respond to storage conditions, ensuring optimal stability and performance over time.
• Shelf-life determination – Establishes the expiration date by monitoring product integrity under real-time and accelerated conditions.
• In-use stability assessments – Examines product stability during typical handling and use, ensuring effectiveness throughout its intended administration period.

 

Expert Support for Your Stability Studies

Our experienced team will design and execute stability studies tailored to your product’s specific needs. We integrate a full range of analytical methods, including in-vitro bioassays, to evaluate biological activity and functional integrity.

Contact us today to discuss how our customized stability testing solutions can support your biologics development.