A case study in converting disposable process scouting devices into disposable bioreactors as a future bioprocessing...

Area of Science:

• Biotechnology
• Bioprocess Engineering
• Cell Culture Technology

Background:

• The SuperSpinner D 1000® (SSD) is a novel mechanically driven/stirred Process Scouting Device (PSD).
• Characterizing mass transfer and mixing is crucial for bioprocess development and scale-up.
• Disposable bioreactors offer advantages in process flexibility and contamination control.

Purpose of the Study:

• To perform mass transfer characterization (k(L)a) on the novel SSD.
• To evaluate the SSD's performance as a disposable bioreactor.
• To compare the SSD's performance with a standard spinner flask and larger stirred bioreactors.

Main Methods:

• Mass transfer characterization using optical sensors to monitor dissolved oxygen (DO) and pH.
• Mixing time studies to assess fluid dynamics within the SSD.
• Cell culture experiments using a model hybridoma cell line.
• Comparison of SSD performance against a 1 L standard spinner flask and a 5 L stirred bioreactor (Biostat®).

Main Results:

• The SSD demonstrated effective monitoring of critical cell culture parameters (DO, pH).
• High mixing times (5.2 min) were observed, comparable to production scale bioreactors.
• Reducing mixing time 3.5-fold increased k(L)a by 30% and improved minimum DO levels from 0% to 20%.
• Maximum viable cell density and protein titer remained within ±20% of historical data from a standard stirred bioreactor.

Conclusions:

• The novel SSD functions effectively as a disposable bioreactor for cell culture applications.
• Optimizing mixing time in the SSD significantly enhances mass transfer and oxygen availability.
• The SSD shows promise for process scouting and scale-up studies, maintaining comparable performance to traditional stirred bioreactors.