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
We perform stability studies in accordance with ICH guidelines using suitable climate chambers at controlled temperatures and relative humidity (RH). This service is offered as part of formulation development projects, supply of preclinical, clinical or commercial material, or as a standalone service package. In addition to supporting formulation development and quality assurance, this data can be used as supportive information for key regulatory filings (IND, IMPD, BLA), 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 | |
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*Virtually any other temperature and relative humidity conditions can be offered. |
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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 Studies Frequently Asked Questions (FAQs)
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Stability studies assess how a drug product’s quality, efficacy, and safety are maintained over time under various environmental conditions. They are essential for selecting the most suitable formulation, determining shelf life, storage conditions, and for supporting regulatory submissions such as IND, IMPD, and BLA.
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Yes. Coriolis designs and executes stability studies in accordance with ICH guidelines using controlled temperature and humidity conditions. These studies support formulation development, quality assurance, and global regulatory filings.
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We offer tailored stability studies for a wide range of biologic modalities, including antibodies, peptides, therapeutic proteins, vaccines, viral vectors, gene and cell therapies, nucleic acids, and nanoparticulate delivery systems.
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Coriolis supports nearly all ICH and product-specific temperature and humidity conditions, including:
- Frozen: –156 °C, –80 °C, –40 °C, –30 °C, –20 °C
- Refrigerated: 2–8 °C
- Controlled room temperature: 25 °C/60% RH, 30 °C/65% RH
- Accelerated: 40 °C/75% RH
- Custom conditions can also be accommodated.
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Yes. Stability studies at Coriolis can be performed under both non-GMP and GMP conditions, depending on your development phase and regulatory requirements. Qualified climate chambers and full quality oversight support GMP studies.
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Data from ICH-compliant stability studies is critical for regulatory filings such as INDs, IMPDs, and BLAs. These studies demonstrate the product’s shelf life and ensure its integrity over time, reducing development risk and regulatory delays.
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Yes. Coriolis has the facilities, expertise, and biosafety level 2 (BSL-2) clearance to handle and store complex biologicals such as viral vectors, live virus vaccines, and other temperature-sensitive or high-potency APIs.
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Stability studies should be initiated as early as preclinical development to understand degradation pathways and guide formulation selection. Coriolis supports studies from early phases through commercialization, aligning with your evolving development needs.
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Typical CQAs include potency, purity, degradation products, pH, particulate content, appearance, and other parameters based on the product type and regulatory guidance. Coriolis helps define and track the most relevant CQAs for your molecule.
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Absolutely. Our stability programs are designed with global regulatory expectations in mind. Whether you’re filing in the US, EU, or other regions, our studies support the full range of ICH stability zones and documentation requirements.
Stability Study Resources
Publications
July 10, 2025
Publications
June 16, 2025
