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Formulation Development

 

Kemwell offers formulation development services for early and late stage clinical development and commercial products based on target formulation profiles. Formulation development work is carried out collaboratively with analytical development groups to ensure that robust and stability indicating analytical methods are used appropriately during formulation development. Accelerated and real-time stability studies, and varieties of stress stability are employed to deliver the best formulation for your product.

 

Preformulation Studies

  • Evaluation of biophysical characteristics
  • Assessment of ‘thermodynamic stability’
  • Identification of critical factors that impact stability

Formulation Screening Studies

  • Formulation screening studies to select optimal formulation for the molecule
  • Integrated formulation and analytical method development team to ensure right methods are available forevaluating degradation routes of molecule to enable formulation screening studies

Lyophilization Cycle Development

  • Lyophilization cycle development for molecules that may have inherently lower stability in liquid form
  • Optimization of each phase of the cycle to ensure an efficient, robust and scalable process

 

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