Long-term stability and biological activity is dependent on maintenance of the protein’s native three-dimensional conformation. We employ biophysical characterization techniques such as circular dichroism, differential scanning calorimetry, FTIR and fluorescence spectroscopy to assess the conformational and thermodynamic stability of proteins under a range of formulation conditions.

These tools allow us to differentiate among various buffer, pH, ionic strength and excipient conditions, and identify the conditions that confer the optimal environment for the therapeutic protein.

Utilizing Advanced Statistical Design for Preformulation Development

Our approach to preformulation development relies on statistical design of experiments (DOE), allowing for simultaneous evaluation of multiple factors and interactions between factors – thus saving valuable time and resources.

Formulation Development for a Wide Range Of Dosage Forms

Our formulation scientists are highly skilled in developing biotherapeutic dosage forms for parenteral, oral, topical and inhalation administration, including liquids, gels, suspensions, emulsions with considerable expertise in lyophilization. Lyophilization cycle development is performed in the context of the unique thermodynamic properties of the API to deliver an efficient, scalable, transferable process resulting in optimal product stability and reconstitution characteristics.

Advantages of the KBI Biopharma Approach

Our approach to preformulation and formulation development results in significant savings to the client, by eliminating the variables associated with suboptimal formulations.

The client can execute preclinical PK, PD, ADME and toxicology studies with confidence knowing that uncontrolled variables from unstable formulations will not be introduced into the study. This benefit extends far into clinical trials as well. By eliminating uncontrolled stability variables, the client can focus solely on therapeutic performance and clinical outcome.