KBI Biopharma

Formulation Development

Biologics Formulation Development

KBI's approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:

• Establishing a comprehensive understanding of the protein's thermal, physical, chemical, and conformational stability.
• 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 focusing solely on therapeutic performance and clinical outcome and resulting in significant savings to the client by removing the variables associated with suboptimal formulations. Preclinical development efforts in PK, PD, ADME, and toxicology occur with confidence that additional uncontrolled variables from unstable formulations are not introduced into the study.This benefit extends far into clinical trials, where the assessment of toxicity, dosage levels, and efficacy are profoundly influenced by an optimal formulation that conserves the three-dimensional conformation of the therapeutic protein. KBI's data-driven approach can also strengthen responses to regulatory inquiries.