Quality Control






 

ASAT/MSAT

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  • Environmental monitoring for regulatory compliance​
  • In-process manufacturing quality testing​
  • Product release analytical testing​
  • Drug Substance and Drug Product Stability testing​

  • Process scalability and GMP suitability assessments
  • Manufacturing process development
  • Technology transfer
  • Product specific analytical testing development

Viral


















 

Non-Viral

  • Viral Vaccine Production: BSL-2 attenuated and inactivated vaccine production
  • Master/Working viral banks (up to 200 vials each)
  • Live challenge viral strains
  • Univercells scale-X™ carbo fixed bed bioreactor 10-30m2 (cell growth area equivalent to 120-360 roller bottles or 16-48 cell stacks with 10 trays (e.g. CellSTACK™-10 layer))
  • Roller bottles – up to 40 roller bottles
  • Cell stacks – up to 10 cell stacks with 10 trays (e.g. CellSTACK™-10 layer)
  • Independent Air Handling to maintain closed environment
  • Vaporized Hydrogen Peroxide decontamination between campaigns





 
  • Microbial fermentation – up to 400L scale
  • Mammalian cell culture – up to 40L scale
  • Master/Working cell banks (up to 200 vials each)
  • Bacterial challenge strains
  • Live attenuated bacterial vaccines
  • Stacked disk centrifuge (Alfa Laval model BTPX 305)
  • Hollow fiber and flat sheet tangential flow systems

Purification

  • Scalable recombinant protein purification expertise: depth filtration, chromatography, tangential flow filtration, and more 
  • Knauer NanoScaler™ for lipid nanoparticle encapsulation and liposome production ​

mRNA

  • mRNA Vaccine Production: in vitro transcription up to 300 mL scale, approximately 1 gram of mRNA  

Fill Finish

  • Final product formulation​
  • Viral and non-viral drug product filling​
  • Manual filling up to 2,000 vials per lot​
  • Lyophilization capability​
  • 2mL – 20mL vial sizes qualified​
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