Pre-Formulation Development 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.

Home About us Process Development GMP Contract Manufacturing Working with Us Quality Careers Contact Us Site Map

Legal Statement and Disclaimer

We use cookies to help understand how people use our website. By using our site, you agree to our use of cookies. Find out more in our privacy policy.