Formulation development is a critical part of every biopharmaceutical development program and important for assuring the quality, safety, and efficacy of the drug product.
Because of the critical nature of pharmaceutical formulation, Scorpius BioManufacturing takes an integrated approach to formulation development beginning early on in the biologics or large molecule production cycle. Formulation development services are performed in coordination with process and analytical method development activities as early as discovery research and remain a priority all the way through product commercialization. Integrating our formulation development and analytical development teams ensures the establishment of a development strategy that accelerates project timelines and reduces risk.
Each drug product often requires a product-specific formulation due to the complexity of different degradation pathways potentially affecting product stability. Our expert formulation development team is highly skilled in optimizing the formulation of a wide variety of biopharmaceuticals, including therapeutic proteins and enzymes, immunotoxins, monoclonal antibodies, protein-based vaccines and cell-based therapies.