Formulation

Formulation services spanning small molecules and biologics, from setting specifications to analytical testing and stability studies.

Development of small-molecule combination products for inhalation from selection of API through to commercialization including formulation. Besides 20 years’ experience of stabilizing complex biologics, vaccines and gene therapy products, clients receive customized development approaches and a flexible, CMC and data science driven project team.

Biologics

  • Molecular Modelling
  • Excipient Pre-Selection
  • Characterization
  • Rational and tailored Formulation Development
  • Process Development for dry powders
  • Analytical Testing
  • Stability Studies
  • In-Use-Studies

Small molecules

  • Selection and qualification of APIs and excipients
  • Formulation development in small scale
  • Process development
  • Scale up support up to commercial scale
  • Definition of specifications
  • Generation of all CMC data