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.
Advantages of the KBI Biopharma Approach
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 as well, where 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.
KBI Formulation Development Experience
The KBI team has completed more than 80 successful protein, peptide, and vaccine formulation development programs. Liquid, lyophilized, and suspension formulations developed by KBI have been successfully transferred to many fill/finish CMO’s and utilized for the manufacture of clinical and commercial drug product for parenteral administration (IV infusion, IV push, SC, IM).