Stability studies
Understanding the long-term stability of your drug product is crucial especially during late-stage development
Stability studies evaluate the long-term stability of a drug product in its final primary packaging material under controlled storage conditions. In regular intervals, the chemical, physical, structural, and colloidal stability of the drug product is assessed by using stability indicating analytical methods.
Critical quality attributes (CQA) and relevant degradation pathways, as identified during preformulation and forced degradation studies, are monitored to assure the efficacy, quality, and safety of the drug product over its intended shelf-life. We perform such studies in accordance with ICH guidelines by using suitable climate chambers at controlled temperature and relative humidity (r.h.). We offer stability studies as part of formulation development projects, supply of pre-clinical material or as independent service package.
At Coriolis, we harness the knowledge gained in hundreds of projects to quickly obtain optimal test conditions for your drug substance, reflecting its major degradation pathways and assessing its critical quality attributes.
Standard storage conditions at Coriolis Pharma include the following*:
| Frozen storage | Storage according to ICH |
|---|---|
|
-156 °C -80 °C -40 °C -30 °C -20 °C |
2-8 °C 25 °C at 60% r.h. 30 °C 40 °C at 75% r.h. |
*virtually any other temperature and relative humidity conditions can be offered as well, e.g., for kinetic studies.
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Our experts are happy to discuss your questions and inquiries related to stability studies.
Stability studies tailored to your drug product
We offer stability studies tailored to your specific API, development phase, packaging material and anticipated storage conditions, and is backed by many years of experience with similar drug products. Click on a product type to explore our entire portfolio of specialized development and analytical services.
Quality & biosafety level of this service
We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:
Our services related to stability studies
Evaluating the long-term stability of a drug product is usually accompanied by other types of stability testing, such as forced degradation studies, in-use stability studies and comparability studies.
Forced degradation studies
Forced degradation studies are essential to understand the criticality of certain types of stress for the stability of drug substance. Our scientists develop and apply conditions, which simulate chemical, physical, or mechanical stress during production, transport and handling.
This knowledge is then applied to optimize the drug product formulation, design better primary packaging, and adjust procedures for production, transport, and handling.
We offer this service under R&D and GMP, and up to Biosafety Level S2
In-use stability studies
In a clinical setting, a drug product may be diluted and encounters different surface materials before it is finally administered to the patient.
Therefore, our expert scientists assess the stability of a drug product during clinical use and handling, e.g., effects of dilution, compatibility with clinical diluents and materials, etc. We tailor such studies to the intended procedures and utilize a dedicated set of stability indicating analytical methods.
We offer this service under R&D and GMP, and up to Biosafety Level S2
Comparability studies
The physico-chemical comparability, including comparability of stability profiles, is required for the development of biosimilar drug products, but can, among other scenarios, be crucial when comparing samples from different production processes or manufacturing facilities.
By using sensitive analytical methods and by applying relevant conditions for stability testing, we set up comparability studies specifically for your drug product. We provide the required experience and scientific know-how to detect critical differences between your samples with statistical relevance.
We offer this service under R&D and GMP, and up to Biosafety Level S2
Our know-how related to forced degradation studies
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:
Knowledge items
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Find out how you can benefit from a tailored stability study from the scientific expert.
Our other services
Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.
Contact us
Contact us
Please contact Dr. Matthias Lucke for inquiries related to stability studies
Phone: +49 89 41 77 60 – 253
Mail: matthias.lucke@coriolis-pharma.com
