Choosing the right partner for product characterization services is critical in the approval race. We partner with biopharma and vaccine developers to provide safer, more reliable, and faster testing to ensure regulatory approval of drugs. We know how difficult it can be to characterize your product throughout the drug development process due to the advanced technology and expertise that is required. Our comprehensive program combines the physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays, helping to understand the function of your drug.
Choose from mAb-based assays or request custom assays designed for novel compound analysis. We conduct specific and sensitive testing through capabilities such as hydrogen/deuterium exchange (HDX), ion mobility, and data independent acquisition capabilities. We offer binding kinetics with association and dissociation rates in real time with BIACORE® technology. All testing is designed to support drug manufacturers from early stages through to commercial batch release in compliance with ICH guidelines and FDA/EMA regulations. Our regulatory experts support the complexities associated with regulated testing.
Our in-house industry experts build your customized package to suite your needs and your unique testing requirements.
- Physicochemical and Structural Assays
- Binding Assays
- Potency and Bioassays
- Stability and Degradation Programs
- Lot Release Testing
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