Take aseptic filling out of the hands of your operators. The success of your advanced therapy medicinal products (ATMPs) depends on getting them to patients safely and effectively.
A safe aseptic process and agile in productivity? Sure.
Easy to use and reduced cost of goods? Absolutely.
Your science is unique, but your aseptic filling machine doesn’t need to be. That’s the choice that innovative companies like Adaptive Phage Therapeutics, Moderna and FUJIFILM Diosynth have made in manufacturing their ATMPs.
Advanced therapies filled by hand in a biosafety cabinet or glovebox isolator isn’t going to cut it–for your patients, for regulators or for the commercial success of your therapies.
Biopharma manufacturing experts designed the Aseptic Filling Workcell to provide an optimal aseptic process that improves drug product quality. And we have the data to prove it.
The Microcell Vial Filler and SA25 Aseptic Filling Workcell are both standard designs that can be built, installed and validated quickly. It’s possible to reach GMP in 6 months with the Microcell and 12 months with the SA25.
It’s possible to switch between drug products in as little as 30 minutes, including decontamination / aeration of the VHP cycle. Your time to fill is also fast to preserve the efficacy of live cells.
Beyond the machine itself, you have an ecosystem of flow paths and multiple sources of compatible vials and press-fit closures that can be frozen to preserve live cells.