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)
