Photo of lab equipment used for biologics formulation development by Scorpion Biological Services on contract development and manufacturing projects

Process Development

Formulation Development

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.

Formulation Development Services

Scorpius' formulation development services are designed to ensure a smooth path for your biologics or large molecule product throughout its lifecycle, no matter the stage or eventual scale of your project. Our many formulation development service offerings include:

  • Optimized formulations to maximize product stability using Process Excellence Six Sigma methodology (e.g., Design of Experiments)
  • Integrated formulation development, process development and analytical method development to optimize product stability
  • Application of Quality by Design (QbD) principles throughout development activities
  • Identification of important process parameters via FMEA analysis
  • Selection and qualification of container closure systems
  • Connection with a third-party CRO experienced in the development and optimization of lyophilization processes for biotherapeutics

Learn more about our commitment to using American-made cGMP-compliant equipment and consumables to find out how we can work with you to develop an optimized formulation for your biologics project.