QbD studies in upstream processing more rapidly performed.

Sartorius Stedim Biotech (SSB) has announced that the ambr 15 automated micro bioreactor system combined with a Nova Biomedical (Nova) BioProfile FLEX2 automated cell culture analyser is on show for the first time at the Cell Line Development & Engineering Conference in San Diego, California. 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.

Sartorius Stedim Biotech’s ambr 15 bioreactor system now can be combined with Nova’s BioProfile FLEX2 automated cell culture analyser.

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 analyse 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 SSB.

"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 analyser."