Principal Scientist Drug Product Development / Bristol Myers Squibb New Brunswick, New Jersey
Novel protein constructs, such as fusion proteins, bispecific antibodies, or antibody drug conjugates, can pose unique formulation and process development challenges. Formulation development strategies and platform approaches that fit many standard monoclonal antibodies may not provide sufficient stability to enable an appropriate drug product use-period for these unique constructs. Therefore, additional formulation screening approaches and stress sensitivity screening studies must often be applied to develop an optimal formulation and robust manufacturing process for these molecules. In this case study, a formulation screening DoE approach was applied to an Fc fusion protein to optimize the formulation for a high concentration drug product presentation. The formulations that provided the most optimal stability profiles were then screened using small-scale tools to assess the impact of interfacial and shear stresses present during drug product development. Combining formulation screening with formulation performance informed not only the storage stability but also the processing operational space needed to maintain integrity of this unique protein drug product in different formulations.
Understand factors to consider when developing a formulation for a novel protein construct
Explore how physical stress can impact protein stability in different formulations
Provide a high level understanding of fusion proteins