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

Process Development

Cell Therapy Development

Scorpius BioManufacturing offers cell therapy process development and manufacturing services that span all phases of the product life cycle, from small-scale, proof-of-concept studies through cGMP-compliant manufacturing.

Scorpius' expert Process Sciences team has extensive experience in the development of robust expansion and cell recovery processes for a number of adherent and suspended cell and cell-gene cell lines, as well as the isolation of cells from a variety of tissue sources.. Whether you are seeking cell therapy process development for small-scale, preclinical evaluation and proof-of-concept studies or cGMP-compliant, clinical-, Scorpius' services can bring clarity to your timeline and procedures.

The extensive development capabilities offered at Scorpius' CDMO biomanufacturing facilities allow us to develop reproducible and 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.

Cell Therapy Development Services

All of our process development services are designed to ensure a smooth path for your cell therapy product throughout its lifecycle, no matter the stage or eventual scale of your project. Scorpius' many cell therapy process development service offerings include:

  • Cell bank development
  • Comparison of 2D vs. 3D technologies with adherent (on microcarriers) and suspended cell formats
  • Process optimization using miniaturized bioreactors with advanced cell culture process control strategies
  • Identification of critical process parameters and quality attributes
  • Provision of extensive PD and optimization studies throughout all stages of development, from 250-mL to 500-L
  • Optimized cell therapy processes using Process Excellence Six Sigma methodology (e.g., Design of Experiments)
  • Application of Quality by Design (QbD) principles throughout development
  • Isolation of mesenchymal stromal cells from bone marrow, adipose tissue and umbilical cord tissue (Wharton's jelly)
  • Process monitoring and control strategies, including metabolic profile analysis
  • Optimization of cell harvesting processes (centrifugation, microfiltration, etc.)
  • Scale-down process validation studies
  • Aseptic process validation and simulation studies
  • Cryopreservation process optimization using controlled-rate freezing strategies

Explore Scorpius' manufacturing capabilities and learn more about our commitment to using American-made cGMP-compliant biomanufacturing equipment and consumables to find out how we can develop an efficient and optimized cell therapy manufacturing process for your project.

Image of equipment and machinery used in Scorpion's Texas cell therapy and biologic manufacturing and development facility in Texas, USA

Scorpius' 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.

Want to learn more about our expert process development capabilities? Let's discuss your
needs
Smiling male CDMO facility worker from Scorpion Biologics Services