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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.

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.

Service Offerings
  • Optimization of formulations to maximize product stability using Process Excellence Six Sigma methodology (e.g., Design of Experiments)
  • Integration of formulation development, process development, and analytical methods development to optimize product stability
  • Application of QbD principles throughout development activities
  • Identification of important process parameters via FMEA analysis
  • Container closure system selection and qualification
  • Established relationship with third-party CRO experienced in the development and optimization of lyophilization processes for biotherapeutics