Mammalian cGMP Manufacturing Capabilities

• Seamless transfer of existing process or scale-up process to GMP manufacturing
• Flexibility in cGMP manufacturing:
  • Stainless steel bioreactors
  • Single-use bioreactors
• Option for single use/disposable solutions in all steps of manufacturing
• Batch, fed-batch and continuous perfusion operation

Microbial cGMP Manufacturing Capabilities

• cGMP manufacturing in Stainless steel fermenters
• Extensive expertise with microbial manufacturing using both bacterial and yeast fed-batch processes
• Continuous centrifugation
• High pressure homogenization
• Secreted proteins and inclusion bodies

Finished Drug Product Manufacturing Capabilities

Our aseptic fill line supports finished parenteral drug product for clinical supply needs.

• Accommodates multiple glass vial configurations
• Manual and fully automated filling lines
• Coordinated labeling and shipping to clinical sites
• Liquid and lyophilized formulations

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