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formulation_development1

Formulation Development

We offer formulation development for early stage formulation as well as commercial drug drug product. We have extensive experience in NBE formulation development. Our services services include development of both liquid and lyophilized presentations. Parallel studies of prototypes are conducted to reduce time lines.

Our services include pre-formulation services along with formulation process development development and compatibility studies with administration components. Parallel studies of prototypes conducted to reduce time lines.

Stand-alone 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

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