Stability Studies
Coriolis Pharma’s expert team designs and conducts ICH-compliant stability studies to ensure the drug product’s efficacy, quality and safety over its intended shelf life. Our stability testing and sample storage accommodate standard temperature ranges and product-specific requirements. Such stability studies are performed for non-GMP and GMP drug products during formulation development in preclinical or clinical phases in conjunction with manufacturing clinical or commercial material.
Stability Studies & ICH Guidelines
As part of formulation development projects, supply of preclinical, clinical or commercial material, or as a standalone service package, we perform stability studies in accordance with ICH guidelines using suitable climate chambers at controlled temperatures and relative humidity (RH). In addition to supporting formulation development and quality assurance, these data can be used as supportive information for key regulatory filings (IND, IMPD, BLA), offering efficiency and lowering risks in later development phases.
The Coriolis team applies the knowledge accumulated from completing hundreds of stability study programs to quickly obtain optimal test conditions for your active pharmaceutical ingredient, reflecting its major degradation pathways and assessing its critical quality attributes.
While nearly all temperature and relative humidity conditions can be offered, standard stability study storage conditions include:*
Frozen Storage |
Storage according to ICH |
|---|---|
| -156°C | 2–8°C |
| -80°C | 25°C at 60% RH |
| -40°C | 30°C at 65% RH |
| -30°C | 40°C at 75% RH |
| -20°C | |
|
*Virtually any other temperature and relative humidity conditions can be offered. |
|
Stability Studies Tailored to Your Drug Product
We design stability studies for all phases of drug development for many different biopharmaceutical drug products, including highly concentrated protein formulations and active pharmaceutical ingredients like live virus vaccines and viral vectors that fall under biosafety level 2.
Your Phase
Throughout the product lifecycle, our expert team has the expertise and experience to design stability studies to meet your needs.
Stability Study Resources
Publications
April 12, 2024
Publications
A Model-Based Optimization Strategy to Achieve Fast and Robust Freeze-Drying Cycles
December 1, 2023
