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Process Development

Mammalian Cell Culture Development

Scorpius BioManufacturing offers cell culture process development services spanning all phases of the mammalian product life cycle, from proof-of-concept studies through the commercial-scale cGMP-compliant manufacture of products.

Scorpius' experienced and accessible process development team leverages their decades of expertise to provide process development services for a variety of projects. Whether you're seeking mammalian cell culture 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.

Mammalian Cell Culture Process Development Services

Every one of our robust selection of PD services are designed to ensure a smooth path for your biomanufactured product throughout its lifecycle, no matter the stage or eventual scale of your product. Scorpius' many mammalian process development service offerings include: 

 

  • Optimized upstream 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
  • Process optimization using miniaturized bioreactors
  • Comparison of 2D vs. 3D technologies
  • Provision of extensive PD and optimization studies throughout all stages of development, from 250mL to 500L
  • Use of advanced cell culture process control strategies
  • Process monitoring, including metabolic profile analysis
  • Optimization of cell harvest processes (centrifugation, kSep, microfiltration, etc.)
  • Aseptic process validation and simulation studies
  • Scale-down process validation studies
  • Optimization of cryopreservation process using controlled-rate freezing strategies

 

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

Want to optimize your mammaliam manufacturing process? Let's discuss your
needs.
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