Stability studies

Securing quality, safety and efficacy over time

At Quality Assistance, we offer a fully integrated approach to stability testing, combining scientific and product-dedicated expertise in analytical sciences, regulatory comprehension and a state-of-the-art infrastructure. We evaluate the physico-chemicals characteristics, biological activity and other attributes of your drug substance or drug product across time for a wide range of storage conditions.

Our team coordinates the full lifecycle of your stability studies, from protocol design and the implementation of stability-indicating to data interpretation and final reporting. We ensure scientific continuity across techniques and full compliance with GMP and ICH guidelines, generating reliable data to meet regulatory requirements.

Our Project Management Team optimises planning and timelines for analytics and report issuance and act as your central and main point of contact for full programme coordination.

Whether you're developing a small molecule or an advanced biologic, we provide the guidance, facilities and methods to generate high-quality, decision-enabling data.

We can manage a wide range of studies:

• Preliminary assessment
• Compatibility studies (DS and excipients, leachables, sorption, migration, degradation of DS)
• Forced degradation studies
• Short-term and long-term studies
• Accelerated and stressed conditions
• Photostability
• In-use stability studies
• Thermal cycling and freeze-thaw cycling studies

We have extensive experience with a variety of matrices, on a wide range of samples, including drug substances, drug products, raw materials, excipients, in-process controls, formulations and packaging materials.

To support your drug development programme from early phase to registration, Quality Assistance offers a complete range of ICH-compliant stability storage conditions, all within a fully GMP-qualified and monitored environment.

Our large-capacity facilities include:

• 150m³ of storage: climatic chambers (including 7 walk-in chambers), refrigerators, freezers including ultra-low temperature and vapour-phase nitrogen systems
• Computerised sample flow management
• 24/7 computerised condition monitoring
• Back-up storage infrastructure
• Back-up electric generators
• In-house maintenance and qualification team
• Secure site (restricted access, alarm system, etc.)

Whether you require standard long-term storage, accelerated conditions, photostability, freeze/thaw cycles or cryogenic temperatures for advanced therapies, we ensure your samples are handled securely and stored under validated and controlled conditions.

Understanding what happens to your product after dilution, reconstitution or preparation for infusion or IV administration is essential, especially in clinical settings.

Before the clinical use of your product, different parameters must be investigated to guarantee the safety of the clinical subjects during the trial.

Thanks to our wide experience in stability studies, we help you to set up the in-use stability protocol according to the clinical administration design, for all modalities. We design and conduct in-use stability studies that reflect real-world administration conditions:

• Compatibility with infusion bags, filters, diluents and devices
• Stability at room temperature, refrigerated or frozen
• Stress conditions: agitation, bubbling, filtration
• Parameters such as appearance, pH, aggregation, concentration, impurities, subvisible particles and biological activity via immunoassays or cell-based assays