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Process Development

Downstream Purification

Scorpion has extensive experience developing recovery and purification processes for a wide variety of recombinant biotherapeutics including therapeutic proteins, enzymes, immunotoxins, monoclonal antibodies, protein-based vaccines, and cellular therapy exosome products.

Our advanced protein characterization capabilities, including conformational and structural analyses via biophysical techniques, allow for critical structure-function studies as well as assessing the refolding of recombinant proteins expressed as insoluble inclusion bodies. Having integrated process development and analytical development teams ensures a development strategy that accelerates timelines and reduces risk.

Service Offerings
  • Experience in developing downstream recovery and purification processes for a variety of recombinantly expressed proteins as well as proteins expressed as insoluble inclusion bodies in E. coli
  • Experience in the isolation and purification of cell therapy exosome-based products
  • Use of Process Excellence Six Sigma methodology (e.g., Design of Experiments) for the optimization of cell therapy processes
  • Application of QbD principles throughout development
  • Identification of important process parameters via FMEA analysis
  • Integration of process development and analytical method development to optimize downstream process steps
  • Inclusion of selective washes to enhance impurity removal
  • Evaluation of product biophysical and biochemical properties to guide downstream process development and optimization
  • Established relationship with third-party CRO experienced in the execution of viral clearance studies