Pharmaron provides services to help clients select the appropriate drug candidate at the discovery stage by assessing physicochemical properties and stability profiles of candidate molecules and determine whether the molecules will fit the upstream and downstream process for future scaling up.
Biotherapeutic molecules are labile and susceptible to a variety of degradation pathways such as hydrolysis, oxidation, deamination and aggregation. Early identification of potential instability issues of a candidate molecule that may result in costly failure during CMC development or clinical development is critically important. In addition, an early understanding of physicochemical properties such as solubility and viscosity is essential for developing appropriate dosage forms for clinical administration.
Developability Assessment Services
- Chemical stability
- Physical stability
- Colloidal stability
- Physicochemical properties
- Upstream cell culture process fit
- Downstream purification process fit