• Unique system offers collection of massive quantities of cell culture data  
  • QbD studies in upstream processing more rapidly performed  
  • On show for the first time at Cell Line Development & Engineering in San Diego   

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has announced  the ambr® 15 automated micro bioreactor system combined with a Nova Biomedical (Nova) BioProfile® FLEX2 automated cell culture analyzer. This newly integrated system, which is a first from SSB and Nova’s successful collaboration, enables rapid at-line sample collection and analysis of massive quantities of key cell culture data.  

SSB and Nova have collaborated to seamlessly integrate the software interface that controls the ambr® 15 workstation for automated parallel processing of 24 or 48 single-use bioreactors (10–15 mL working volume) with the cell culture analysis capabilities of the innovative BioProfile FLEX2. The combined system provides a unique tool to simultaneously run, sample and analyze a massive number of cell culture conditions during cell line and media development by Design of Experiments (DoE).

Combining the ambr® 15 and the BioProfile® FLEX2 enables fully integrated automatic sample transfer, analysis and automated feedback control in each single-use ambr® 15 bioreactor. This allows collection of enormous quantities of cell culture data, including total and viable cell density, viability, cell diameter, pH, PCO2, PO2, glucose, lactate, glutamine, glutamate, ammonium, Na+, K+, Ca++ and osmolality, which can be sampled and measured with a complete cycle time of just 6–7 minutes. The ambr® 15 software simultaneously acquires the BioProfile® FLEX2 data set and processes it, for example, by performing complex in-run calculations of how much feed volume to automatically add during a run. This saves time by significantly increasing the amount of consistent clone selection, media development and culture parameter data that a scientist can generate per run.  

“We have combined two highly innovative technologies. Our successful partnership with Nova has delivered complete at-line analytics capabilities for our ambr® 15 platform. Utilizing these integrated systems will support scientists to more easily run full QbD studies, without causing a sampling bottleneck or needing additional staff resources. The new system will optimize their process productivity, as well as the quality of their biologics,” stated Dr. Barney Zoro, ambr® Product Manager at Sartorius Stedim Biotech.  

“There is a significant demand for fully automated cell culture analysis of small-volume culture systems like the Sartorius ambr® micro bioreactor system,” said Matthew McRae, Biotechnology Sales Product Line Manager at Nova. “We’re excited to have worked with SSB on this integration program because our BioProfile FLEX2 with maintenance-free sensors provides rapid analysis of key cell culture tests using just 265 microliters of sample. As a result, this analyzer is a highly complementary addition to the ambr® 15 while maintaining the flexibility and modularity of the first-generation BioProfile FLEX analyzer.”