Formulation Development

Our team of highly skilled scientists can develop your NBE into an optimum and compliant formulation both in liquid and lyophilized presentations for early stage and commercial drug product.

We offer pre-formulation services along with formulation process development and compatibility studies with administration components.

Standalone services offered are:

  • Pre-formulation studies for development of drug product composition.
  • Process development including lyophilization cycle development and optimization.
  • Scale-up and technology transfer support.
  • Spray dried protein formulation development.
  • Drug substance and drug product stability studies as per ICH guidelines.
  • Characterization of degradation and aggregation mechanisms.
  • Drug Product compatibility studies with processing and administration components.