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Press release - for immediate release

01 March 2016

New paper from WuXi AppTec on Shortening Timelines for Bioprocessing of Protein-based Therapeutics Presents data on how scientists at WuXi AppTec are using the ambrĀ® 15 system as a tool to accurately mimic the culture environment of bench-top and production scale bioreactors

Sartorius Stedim Biotech (SSB) today announced a new paper entitled, 'Shortening Timelines for Upstream Bioprocessing of Protein-based Therapeutics' has been published in the journal, BioPharma Asia. The paper details how scientists at leading Asian pharmaceutical company, WuXi AppTec are using the ambrĀ® 15 automated micro bioreactor system to mimic bench-top and production scale bioreactors, producing comparable results with cell growth, cell metabolism and protein production, including similar protein titre to BIOSTAT STR single-use bioreactors.

In the article, one case study describes how WuXi AppTec scientists have applied the ambr 15 system to prove similar cell growth and productivity as 1L and 3L bioreactors, with similar pH and pCO2 profiles using three different monoclonal antibody (mAb) expressing Chinese Hamster Ovary (CHO) cell lines.

The paper also details another WuXi AppTec case study using a mAb-expressing CHO cell line in a fed-batch process in ambr 15 micro scale bioreactors, a 7L glass bioreactor, a 10L single-use bioreactor and a 200L single-use BIOSTAT' STR bioreactor (SSB). The results showed that the growth profiles from the ambr 15, bench-top and production scale single-use bioreactors also had good comparability.

The success of the ambr 15 as a bioreactor mimic in these studies is due to a combination of pH & DO control, culture stirring by an impeller and gas supply by sparging, just as in bench-top and manufacturing scale bioreactors. It is these features which allow scientists at WuXi AppTec to move towards replacing their traditional shake flasks and bench top bioreactors with ambr 15, to increase scalability of early stage results and accelerating their bioprocessing workflow.

Dr. Barney Zoro, ambr 15 Product Manager, at SSB commented: 'The large dose volume needed to achieve clinical efficacy and extensive production and purification steps involved, means that manufacturing costs of biologics can be high. These factors are driving the search for methods and systems to reduce the cost of goods (COGs) of producing biologics.'

Dr. Zoro added: 'This new paper shows how a forward thinking pharma company can reduce the COGs of biologics through an increase in upstream cell culture productivity. By using an automated micro bioreactor system WuXi AppTec's scientists have demonstrated that bioprocess optimisation no longer needs to be limited by availability of bench-top bioreactors, operator time or facility infrastructure and this could in future contribute to reducing their development timelines and the manufacturing costs of their protein-based therapies.'

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