Biologic Drug Substance & Drug Product Formulation

To date, KBI has conducted over 130 successful protein, peptide, and vaccine formulation development programs. KBI's approach to formulation development is based on the strategic pairing of two complementary scientific disciplines: Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein. Employing statistical design-of-experiment (DOE) to evaluate main effects and interactions effects on protein stability Together, these techniques enable KBI to develop robust formulations by eliminating uncontrolled stability variables, thus placing the focus solely on therapeutic performance and clinical outcome.