Process Development

Cell Therapy Development

Cell therapy process development activities at Scorpion span all phases of product development, from small-scale, preclinical evaluation and “proof-of-concept” studies to the development of cGMP-compliant, clinical-scale processes, through to commercial-scale process development.

The Scorpion team has extensive experience in the isolation of cells from a variety of tissue sources as well as the development of robust expansion and cell recovery processes for a number of cell and cell-gene cell lines.

Service Offerings
  • 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
  • Isolation of mesenchymal stromal cells from bone marrow, adipose tissue, and umbilical cord tissue (Wharton’s jelly)
  • Process optimization using miniaturized bioreactors
  • Comparison of 2D vs. 3D technologies
  • Cell bank development
  • Ability to provide extensive process development and optimization studies throughout all stages of process development from 250mL to 2000L
  • Use of advanced cell culture process control strategies
  • Process monitoring capabilities including metabolic profile analysis
  • Optimization of cell harvest process (centrifugation, kSep, microfiltration, etc.)
  • Scale-down process validation studies
  • Aseptic process validation/simulation studies
  • Cryopreservation process optimization using controlled rate freezing strategies

Scorpion’s process development capabilities allow us to develop robust, reproducible, scalable manufacturing processes to accelerate a client’s clinical development program. Development programs typically include transition from open 2D culture systems to functionally closed 3D bioreactor systems, scale-out or scale-up to meet dosing requirements, optimization of cryopreservation, and product comparability studies.