Protein Formulation and Stabilization

ABT has extensive experience in developing stabilizing formulations for proteins in solution. Formulations have been developed by ABT staff to stabilize proteins at low temperatures, ambient temperatures, and at very high temperatures that can occur during un-refrigerated shipping. ABT also has the expertise to stabilize proteins as suspensions and dried powders. 
In developing stabilizing formulations of a therapeutic or diagnostic protein, ABT monitors a protein’s biological activity, physical stability, and chemical stability under conditions that are compatible with the client’s application.  ABT can thus supply the client with a protein that will be active at the start of  in vitro and in vivo testing.

Formulation and stabilization services include:

• Formulation Development
  • Solution Formulation
    • Solution components such as pH, ionic strength, buffer components, and excipients optimized
    • Stability studies peformed at different temperatures
    • Proteins analyzed for biological activity as well as physical and chemical stability
  • Suspension and Dry Solid Formulation
    • Protein’s analyzed for stability as a function of formulation preparation, storage, and reconstitution
    • Particle size and formulation stability monitored
• Protein Stabilization
  • Formulation components tested that are compatible with client’s final application
  • Formulations monitored over time for chemical (e.g. deamidation, fragmentation) and physical (e.g. aggregation, solubility) stability