Press Release

New ambr® 250 Modular Bioreactor Vessel Launched for Cell andGene Therapy Applications••New vessel is designed for gentle stirring and optimum growth of cell lines
Cost-effective, scalable process development of cell and gene therapies

Goettingen, GER | Royston, UK – June 27, 2019: Sartorius Stedim Biotech (SSB), a leadinginternational partner of the biopharmaceutical industry, today launched a new vessel for its
ambr® 250 modular benchtop automated mini bioreactor system. The single-use vessel has been
specially designed for therapeutic cell lines and offers the potential for accelerated processdevelopment of cell and gene therapy applications and scale-up into cGMP single-use
bioreactors and bags.
The new unbaffled vessel design with a large pitched blade impeller has a working volume of
100-250 mL and provides an environment for gentle agitation and mixing without
sedimentation, allowing optimal growth of single cell suspensions, cell aggregates or adherent
cells on microcarriers. In trials with leading regenerative medicine companies, the new minibioreactor has shown better cell culture performance compared with less predictive spinner orT-flask models, enabling rapid process optimization and improved scalability to larger bioreactors.
To further support culture of these cell lines, ambr® 250 modular systems also feature a newstate-of-the-art motor (100rpm-4,500prm), ideal for the lower stirrer speeds required by delicate
therapeutic cell lines. The system is suitable for culturing cell lines including such as HEK293,
CAR-T and other therapeutic cell lines, including a range of stem cells, enabling scalable media
and supplement optimization, as well as process development of cell and gene therapies.
The bioreactor system is available with optional BioPAT® MODDE software for DoE (Design ofExperiments), to support QBD (Quality by Design) for scale-up to SSB’s BIOSTAT® STR stirredbioreactors and scale-out to BIOSTAT® RM TX rocking bags suitable for cGMP production of
autologous and allogeneic cell and gene therapies.
"The ambr® 250 systems are established as the biopharma industry standard small scale model forbiologics process optimization, and we have been approached by numerous scientists developing
cell and gene therapies to extend our technology for these applications,” explained Dr. BarneyZoro, ambr® Product Manager at Sartorius Stedim Biotech. “We have responded by designing anew vessel for the ambr® 250 modular system to provide a single-use platform, with a clear
scalable pathway to our bioreactors and bags for clinical production of regenerative medicines.
Researchers utilizing this workflow, can benefit by reducing time-lines and minimizing
manufacturing costs, thus allowing larger patient numbers to access these revolutionary
therapies sooner,” Zoro added.

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Image files:Figure 1: The new mini bioreactor unbaffled vessel design with a large pitched blade impeller,
enables a gentle stirring and optimum growth of cell lines.

Figure 2: The ambr® 250 modular bioreactor system can now even be used for cell and genetherapy applications.

Download Links:
Figure 1: ambr 250 modular_new vessel
Figure 2: ambr 250 modular_cell and gene therapy
For more details on the upgraded ambr® 250 modular system, scientists should go to this link:
https://www.sartorius.com/en/products/fermentation-bioreactors/ambr-multi-parallelbioreactors/ambr-250-modular
Follow Sartorius Stedim Biotech on Twitter @Sartorius_Group and on LinkedIn.

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A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a totalsolutions provider, the company helps its customers to manufacture biotech medications safely, rapidly andeconomically. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist ofEuronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and aninternational network of sales companies, Sartorius Stedim Biotech has a global reach. The Group has beenannually growing by double digits on average and has been regularly expanding its portfolio by acquisitionsof complementary technologies. In 2018, the company earned sales revenue of €1,212.2 million, andcurrently employs some 5,800 people.

Contact: Dominic Grone, Trade Press Manager, Sartorius Stedim Biotech GmbH,
Phone: +49(0)551.308.3324, email: dominic.grone@sartorius.com, www.sartorius-stedim.com