Allegro STR Single-use Stirred Tank Bioreactors

The Allegro STR bioreactor family has a direct bottom-driven impellor allowing power inputs up to 0.25 W/kg, resulting in high oxygen transfer rates and short mixing times.

From the outset of the design, the focus was on achieving the highest cell culture process assurance by introducing several easy and intuitive operation features:

• The single bottom-mounted impeller allows the biocontainer to be packed into a compact unit that can be placed directly into the hardware with minimal operator manipulation
• Installation and inflation of the biocontainer is achieved in < 30 minutes through a guided sequence via the Human Machine Interface (HMI)
• The low aspect ratio of the systems minimize the operations that have to be performed at height
• Automatic biocontainer deflation speeds up turnaround time, minimizes operator activity and reduces the overall volume of waste for disposal

All product contact surfaces in the Allegro STR bioreactors are single-use components therefore the demands on maintenance, cleaning and cleaning validation are minimal. This makes single-use bioreactors the first choice for process development, CMO plants or multiproduct manufacturing facilities where maximum flexibility is required.

Extensive experiments were performed to characterize the bioreactor and gather data on mixing, mass transfer and cell culture performance. Additionally, all components of this bioreactor were rigorously tested, and several long term experiments were completed in order to ensure the integrity and compatibility of the materials with regards to cell culture demands. During the product development, numerous 28 to 45 day life tests were also performed under maximum operating conditions to prove the design of the single-use system: no leaks were observed during this testing. A smaller number of life tests were also performed for >100 days continuous operation with no leaks observed.