Photo of lab equipment used in downstream purification processes by Scorpion Biological Services

Process Development

Purification Process Development

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

Scorpius BioManufacturing's advanced protein characterization capabilities, including conformational and structural analyses via biophysical techniques, allow for the performance of critical structure-function studies as well as the assessment of refolding recombinant proteins expressed as insoluble inclusion bodies.

The extensive downstream purification process development capabilities offered at Scorpius' CDMO biomanufacturing facilities allow us to develop reproducible, scalable manufacturing processes to accelerate a client's clinical development program. We take an integrated approach to process development that links together PD and analytical development teams to ensure a development strategy that accelerates timelines and reduces risk.

Downstream Purification Process Development Services

Whether you're seeking downstream purification process development for small-scale, preclinical evaluation and proof-of-concept studies or cGMP-compliant, clinical- or commercial-scale processes, Scorpius' PD services can bring clarity to your timeline and procedures.

Scorpius' many downstream purification process development service offerings include:

  • Downstream recovery and purification process development for recombinantly expressed proteins
  • Downstream recovery and purification process development for proteins expressed as insoluble inclusion bodies in E. coli
  • Isolation and purification of cell therapy exosomal products
  • Optimized cell therapy processes using Process Excellence Six Sigma methodology (e.g., Design of Experiments)
  • Application of Quality by Design (QbD) principles throughout development
  • Identification of important process parameters via FMEA analvsis
  • Integration of process development and analytical method development to optimize downstream purification steps
  • Selective washes for enhanced impurity removal
  • Evaluation of products' biophysical and biochemical properties to guide downstream process development and optimization
  • Connection with a third-party CRO experienced in performing viral clearance studies

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 DSP process for your biologics or large molecule project.