Aseptic Filling

Biomay offers cGMP fill & finish services for DNA, proteins and RNA

Fill & Finish Services

  • Fill & finish services for drug product (IMPs for clinical phases I – III)
  • Applicable for plasmid- and linear DNA, proteins, mRNA, guide RNA
  • Automated aseptic filling / stoppering in class A / ISO 5 isolator
  • Sterile 0.2 µ filtration
  • Aseptic lyophilization / freeze drying in isolator
  • Liquid/aqueous solutions or formulations (e.g. alum)
  • Capacity up to 1500 2R glass vials per batch (5R, 10R, 20R alternatively)
  • Media fill validation (aseptic process simulations, APS)
  • Formulation development
  • Stand-alone aseptic filling projects (starting from bulk recieved)