Image of equipment used in microbial fermentation development processes by Scorpion

Process Development

Microbial Fermentation Development

Scorpius' process development staff has extensive experience in optimizing microbial fermentation batch and fed-batch processes for the production of protein biologics, therapeutic enzymes and plasmid DNA at our CDMO biomanufacturing facility. 

Whether you're seeking microbial fermentation 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. We utilize an expandable benchtop single-use stirred bioreactor system for statistical design or experiments (DOE) and process optimization studies.

The extensive microbial fermentation process 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.  

Microbial Fermentation Process Development Services

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

  • E. coli recombinant expression platforms for producing therapeutic proteins and plasmid DNA
  • Optimized upstream fermentation 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 analysis
  • Processes scalable from bench-scale to 100 L
  • Use of advanced cell culture process control strategies
  • Process monitoring, including metabolic profile analysis
  • Optimization of cell lysis (mechanical vs. chemical)
  • Optimization of cell harvest separation process
  • Scale-down validation studies

 

Explore Scorpius BioManufacturing's complete list of microbial fermentation capabilities and learn more about our commitment to using American-made cGMP-compliant biomanufacturing equipment and consumables to find out how we can work with you to develop an efficient and optimized microbial manufacturing process for your project. 

Image of equipment used in microbial fermentation development processes by Scorpion

Scorpius' process development staff has extensive experience optimizing microbial fermentation batch and fed-batch processes for the production of protein biologics, therapeutic enzymes and plasmid DNA. We utilize an expandable, benchtop, single-use, stirred bioreactor system for statistical design of experiments (DOE) and process optimization studies.