Protein Formulation and Process Development along with GMP Fill Finish Services from a Single Experienced Source

White Papers

Ten Major Factors in Successful Protein Formulation Development

Key information required for developing good protein formulations. Includes discussion of Relevant Stresses, Major Degradation Products, Stability Indicating Assays,  Basic Formulation Parameters for Stability, Key Inactive Ingredient(s), Liquid or Lyophilized, Protein Concentration, Delivery Options, Container/Closure Systems and Intellectual Property.

Available in two formats: pdf article, powerpoint

Why Thermal Analysis is Not Relevant for Storage Stability

Some contact formulation groups are touting thermal analysis for identification and prioritization of lead candidates. While this is convenient and useful for small academic studies, the Integrity Bio team feels that it can lead to the choice of the wrong clinical formulation. The wrong choice may lead to future stability and aggregation issues which may also impact safety and efficacy in addition to shelf life. 

Available format: pdf article