Unique, single-use perfusion system offers a fast-track to intensified
cell culture process development
Product innovation being unveiled at BPI West Conference, San Francisco, USA
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry today announced the launch of the ambr® 250 high throughput (ht) perfusion, a new automated parallel bioreactor system. It has been specially designed for rapid cell culture perfusion process development to optimize production of therapeutic antibodies. The system will be launched at the BPI West 2018 Conference in San Francisco, USA (19-22 March, 2018).
The ambr 250ht perfusion system has been developed in collaboration with major biopharma companies. It combines 12 or 24 single-use perfusion mini bioreactors (100-250 mL working volume) with associated single-use perfusion components, all controlled by one automated workstation. The combination of this multi-parallel processing capacity and fully single-use perfusion vessel enables scientists to perform more perfusion culture experiments in a fraction of the time and cost of using traditional perfusion-enabled bench top bioreactors. This new innovation supports a range of hollow fiber perfusion applications, enabling Design of Experiments (DoE) studies for high cell density process development in a Quality by Design (QbD) approach.
Central to the system is the novel perfusion bioreactor assembly, which is based on the established and award-winning ambr® 250 bioreactor design. Intensified cell culture processing is enabled via new components such as high efficiency spargers, perfusion pump chambers and an industry standard hollow fibre for cell retention filter. The geometrical similarity of the mini perfusion bioreactor design to BIOSTAT STR® pilot and manufacturing scale bioreactors, enables rapid scale-up of optimized perfusion processes, and shorter development timelines.
The ambr 250ht perfusion system is simple to set up and use, due to the fully assembled and irradiated perfusion bioreactors which include all the essential components. This includes single-use sensors to continuously monitor pressure at the culture fluid inlet and permeate outlet, enabling online monitoring of transmembrane pressure, as well as standard parameters such as pH and DO.
Dr Barney Zoro, ambr Product Manager at Sartorius Stedim Biotech, explains: “By introducing our new ambr 250ht perfusion system, we are offering our customers an important enabling technology for early-stage development of intensified cell culture processes. Transitioning from fed-batch to perfusion culture offers the potential to reduce capital intensive risk by using 1-2000L single-use bioreactors instead of 10,000L production volumes in stainless steel. ambr 250ht perfusion is a predictive process development tool that could lower the cost of goods of antibody production, as well as significantly shortening development time