Formulation development is a critical part of every biopharmaceutical development program and important for assuring the quality, safety, and efficacy of the drug product.
Formulation development efforts interact with process and analytical development activities as early as discovery research, all the way to product commercialization. Each drug product often demands a product-specific formulation due to the complexity of different degradation pathways potentially affecting product stability.
Our development team is highly skilled in optimizing the formulation of biopharmaceuticals, including therapeutic proteins and enzymes, immunotoxins, monoclonal antibodies, protein-based vaccines, as well cell-based therapies. Having integrated formulations development and analytical development teams ensures for a development strategy that accelerates timelines and reduces risk.
