No matter the complexity of your protein, our expert teams will develop a solution that optimizes its efficacy in the finished form. We provide formulation development services for liquid and lyophilized drug product, in vials or prefilled syringes.
Once the optimal excipients have been selected, we perform stability studies according to ICH guidelines as well as applying a number of stability-indicating methods to ensure the long-term safety and efficacy of the product.
Formulation Development Capabilities
- Scouting by stress and accelerated stability studies
- Estimation of product’s shelf-life by long-term stability programs
- Development of drug product formulation for fill-finish at pilot scale
- Development of specifications for both drug substance and drug product