Da Yu Protein Sciences – Protein Preformulation
The objective of protein formulation development is to deliver a stable product consistent with the Target Product Profile (TPP). Protein preformulation encompasses the initial experiments that define the formulation strategy for a specific protein. In essence, it outlines the working space for formulation development.
There are two characteristics to consider during protein preformulation: protein stability and protein solubility. Ideally, protein preformulation experiments should gather as much information as possible for these two characteristics without requiring significant amounts of protein. Towards this end, a preformulation strategy should follow design of experiment (DOE) principles and a high-throughput screening strategy.
Da Yu Protein Sciences utilizes both full- and fractional-factorial DOE approaches coupled with high-throughput Differential Scanning Fluorimetry (DSF) using a library of GRAS (generally regarded as safe) excipients to define a thermal stability profile for target proteins. Favorable conditions within the protein’s stability profile can then be used to assess the protein’s solubility.