Formulation Development


Drug product formulation development starts with an understanding of the drug substance. Our experts work with you to define and understand the anticipated use, desired performance criteria, characteristics of the drug product, distribution, storage, and stability.

Lifecore’s experienced formulation scientists work closely with your formulation scientists to ensure knowledge transfer and design of an efficient drug product manufacturing process that meets your requirements.

We have the proven expertise to perform a wide array of DoE studies using your product’s CQAs. Risk management techniques can be used to ensure process risks are adequately mitigated.

Examples of these are:

  • exposure to light, oxygen and extreme temperatures
  • mixing conditions and vacuum conditions
  • materials of construction of formulation vessels/piping
  • primary container composition are adequately mitigated