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.
Please visit our Protein Stability page and our Protein Solubility page for more information on these services.