Pre-Formulation and Formulation Development

Pre-formulation studies are designed to learn about the protein's susceptibility to a variety of relevant stresses, develop a baseline biophysical profile for the protein and determine potential degradation pathways of the product. Formulation development will develop a suitable liquid or lyophilized formulation for drug substance or drug product to ensure stability of the protein during pre-clinical, clinical and commercial use.

At FUJIFILM Diosynth Biotechnologies we design tailored protocols to suit specific customer requirements. Individual studies include, but are not limited to:

  • Biophysical characterization - CD, DSC, DLS, FT-IR, Fluorescence, Micro-Flow Imaging™
  • Physicochemical characterization using a broad range of spectroscopic, chromatographic (including UPLC™) and electrophoretic techniques
  • Applying design of experiment (DOE) to formulation development
  • Accelerated stability studies, encompassing a comprehensive suite of stability indicating analytical methods
  • Contact compatibility with materials used during manufacture, storage and clinical use
  • Compatibility with containers and closures

FUJIFILM Diosynth Biotechnologies offers intelligent scientific concepts and design to ensure high quality and rapid development.

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