Stability Testing
State-of-the-Art Services for Your New Drug Product
At Cytovance Biologics, we work to ensure you are provided with the core stability data package to exemplify the quality of your new drug substance and confidently set it on the path to patients.
Delivering a Complete Stability Package
Cytovance has the capabilities to perform all stability-indicating tests for drug substances and drug products at various temperature and humidity conditions. We design your stability program to meet the needs of your product with assets such as identification, functional assays, physical tests, and endotoxin. Our genetic stability testing capabilities can be used to ensure your protein expression construct is stable throughout the production life cycle and guarantee consistent quality of both your product and the manufacturing process.
Committed to ICH Standards
Stability testing is a critical aspect of any early-phase drug development product and informs a range of long-term decisions as the product lifecycle continues. As your reliable CDMO partner, we are committed to providing stability programs and analysis on a regiment that is fully compliant with all guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We factor in environmental influences such as temperature, humidity, and light to generate data on how the quality of your drug substance or drug product is impacted and utilize this evidence to establish recommended shelf life and storage conditions.
Stability Chamber Options to Fit Your Design
Whether it be accelerated or stressed stability testing at higher temperatures or long-term storage conditions, our facilities house a range of stability chamber options to suit the needs of your product. Our experienced team works with you to establish a smart stability program that will give you a complete understanding of your molecule and production process through insightful, high-quality data.
Early-Stage Manufacturing Insight
In addition to providing stability-indicating services for final drug substance and drug product, our team implements a stability regimen as early as possible in the development and manufacturing process to give you advanced insight into all product properties. This can include excipient screening or downstream purification design to optimize the quality and durability of your final product.
Related Areas of Expertise
Analytical and Microbial Testing
Analytical and microbial methods and insights tailored to your product.
Contact Us
Meet Team Cytovance in 2026!
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– BIO Investment and Growth Summit: March 2-3, Miami Beach, FL
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– OPCU Large Molecule: March 24, Virtual
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– World Vaccine Congress: March 30-April 2, Washington D.C. | Booth 536
– PEGS: May 11-15, Boston, MA -
– TIDES USA Oligonucleotide & Peptide Therapeutics: May 11-14, Boston, MA
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– BIO International Convention: June 22-25, San Diego, CA | Booth 4445
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– BioProcess International East: September 22-25, Boston, MA
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– CPHI Europe: October 6-8, Milan, Italy
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– CDMO Live Americas: October 19-21, Boston, MA
- – OPCU Large Molecule: October 27, Virtual