Computer generated image of a DNA helix representing Scorpion Biological Services' cell therapy development and manufacturing capabilities

Process Development

Cell Therapy Development

Cell therapy process development activities at Scorpion's biomanufacturing facility 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 2,000L
  • 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
Image of equipment and machinery used in Scorpion's Texas cell therapy and biologic manufacturing and development facility in Texas, USA

Scorpion’s process development capabilities at our CDMO biomanufacturing facilities 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.