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Press release - for immediate release

17 May 2017

Sartorius Stedim Biotech Partners with Nova Biomedical - Firms combine ambr® technology with the BioProfile® FLEX2 - Unique tool will allow massive quantities of cell culture data to be collected during upstream processing QbD studies

Sartorius Stedim Biotech (SSB), a leading international supplier to the biopharmaceutical industry, today announced an agreement with Nova Biomedical (Nova), a well-known US manufacturer of cell culture analyzers, to integrate their BioProfile® FLEX2 into the ambr® multi-parallel bioreactor systems for automated, at-line cell culture analytics.

SSB and Nova are collaborating to combine two highly innovative technologies. Both the BioProfile® FLEX2 analyzer and the parallel bioprocessing functionality of the ambr® create a
unique tool able to simultaneously run, sample and analyze a massive number of cell culture
conditions during high-throughput cell line, media and process development by Design of
Experiments (DoE). This will allow biopharmaceutical companies to develop well-characterized
cell culture processes in less time while preventing the process development bottleneck being
shifted to the analytical laboratory.

The partnership will deliver full integrated analytics for the ambr® 15 cell culture system in Q3
2017 and later in 2017 for the ambr® 250 high throughput. The ambr® platform mimics the
characteristics of classical bioreactors at the microscale by allowing automated parallel
processing of single-use bioreactors. Integrating ambr® and the BioProfile® FLEX2 will benefit
users by allowing independent sampling, sample transfer, analysis and automated feedback
control in each mini bioreactor.

Stefan Schlack, Senior Vice President Marketing and Product Management at SSB, said: "The
combination of ambr® and Nova's BioProfile® FLEX2 solution saves time by significantly
increasing the amount of data that can be generated per run. Together with our Umetrics and
BioPAT® MFCS software suites, this will offer a complete solution to generate and analyze the
vast amounts of data required for a QbD approach to upstream bioprocess development."

"We're very excited about this collaboration", said Nicholas Theodore, Senior Vice President of
Global Sales for Nova Biomedical. "The combination of Nova's expertise in automated cell
culture analysis and Sartorius' talent in delivering micro-scale smart reactors will yield
tremendous benefits for the biotech industry. The integration of BioProfile® FLEX2 with the
ambr® cell culture systems will result in accelerated commercialization of products and the
ability to develop more products at lower cost, while ensuring the best quality of biotherapeutics
for patients worldwide."
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