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.