Our Integrated Solutions team designs, delivers and implements rapid and cost-effective biomanufacturing platforms

Connect Upstream for Robust Production

Our Integrated Solutions team designs, delivers and implements rapid and cost-effective biomanufacturing platforms – from process development to clinical to commercial manufacturing.

We combine our unmatched expertise in single-use bioprocess engineering with our fully integrated upstream platform and outstanding bioprocess technology portfolio for your process development, facility design and regulatory compliance. Discuss your manufacturing plans with us at any time.

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Our Latest Upstream Innovations:

A Perfect Match for True Scalability in Single Use

The BIOSTAT STR® fully scalable, single-use bioreactor family offers working volumes from 12.5 L to 2000 L and is based on conventional stirred-tank design. It is now available in its 2nd generation with improved hardware design, Flexsafe STR® bags for excellent cell growth and robustness as well as with single-use, non-invasive biomass monitoring.

More about BIOSTAT STR® and Flexsafe STR®

 
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Robust Production – Reliable processing up to 2000 liters

BIOSTAT STR®

Let BIOSTAT STR® become your single-use bioreactor platform. Achieve excellent performance for high cell-density fed-batches due to excellent mixing, oxygen transfer and CO2 stripping. Successfully grow your shear sensitive cells on microcarriers in suspension culture thanks to the flexible stirrer and sparger options.

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Robust Production – Reliable processing up to 2000 liters

Flexsafe®

Flexsafe® bags ensure excellent and reproducible growth behavior, even with the most sensitive cell lines. Use our Flexsafe STR® bags for clinical or commercial production of your valuable product. Team up with our Flexsafe® RM bags in your seed train and our 3D bags for media storage. Benefit from the same polyethylene film material across all your cell culture steps.

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"The Sartorius Stedim Biotech
team’s performance
surpassed our expectations."

"We now have a highly flexible facility with scalable, disposable equipment from 50 L to 2,000 L designed to meet the rapidly changing requirements of our clients."

“The Sartorius Stedim Biotech team’s performance surpassed our expectations.”

Ge Li, Ph.D., Chairman and CEO of WuXi AppTec

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Case Study: WuXi AppTec

Our Integrated Solutions team worked closely with WuXi AppTec Biopharmaceuticals Co. to establish the first fully single-use manufacturing faciltiy in China. Based on an analysis of various production scenarios, a highly flexible multi-product facility was built in record time.

WuXi AppTec Biopharmaceutical Co. is a leading global pharmaceutical, biopharmaceutical and medical device outsourcing company.

Project Details

  • 100% closed single-use technology for pre-|clinical trial material
  • Compliant with US, EU and Chinese cGMP standards
  • Cell culture platform for multi-host mammalian cell lines
  • Expression titers up to 5 g/L
  • Multi-product capability
  • Flexible plug-and-play production (50-1,000 L)
  • Completed on schedule within an 18-month timeframe


The facility was recognized with an honorable mention by the International Society of Engineering at the 2014 Facility of the Year Awards "for their innovative bioprocess platforms and flexibility in scale and process adaptability."

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Bioprocess Knowledge Is Power

by Nick Hutchinson, Floris De Smet and Miriam Monge, September 2016

Developing an in-house bioprocessing competency prevents companies becoming dependent on external contractors. Single-use technology has greatly reduced the upfront costs required to install biomanufacturing capacity. In this article, the authors describe how a company can leverage external expertise in order to acquire the necessary skills to establish an internal production capability.

Download Medicine Maker article

Tutorial: Enabling Viral Vaccine Production

by Amélie Boulais, Nick Hutchinson and Fritjof Linz, September 2016

Single-use process platforms are helping biopharma companies reach the clinic more quickly and at lower cost.  In this tutorial we describe how manufacturers of Adenovirus vectors can use one such platform straight-from-the-box and with minimal optimization. Adopting a platform approach allows manufacturers to reduce time spent on process development and minimize engineering work when installing production capacity.

Download GEN tutorial

Continuous Cell Culture Operation at 2,000-L Scale

by Michael Sherman, Vincent Lam, Melissa Carpio, Nick Hutchinson and Christel Fenge, November 2016

In this article, the authors present data from a client showing the BIOSTAT® STR, single-use bioreactor to be highly effective for performing continuous cell cultures at the 2000-L scale. So efficient was the oxygen transfer within the BIOSTAT® STR it raises the possibility the client could perform a very demanding process in the single-use format that had, until this point, only been feasible within a stainless steel bioreactor.

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Perfusion Cell Culture Processes: WuXi’s experience from China | WuXi Biologics sees an opportunity to start with a clean slate

by Nick Hutchinson, December 2016

Perfusion cell culture in single-use bioreactors is attracting considerable interest within the biopharmaceutical industry as an alternative to batch processes operated in large-scale stainless steel vessels. Dr Weichang Zhou (Senior Vice President, Biologics Development and Manufacturing) described WuXi Biologics’ approach to continuous bioprocess at Sartorius Stedim Biotech’s ‘China Bioprocess and Integrated Solution Innovation Forum’ held in September, 2016. Read an interview with Dr Zhou in which he discusses how intensified bioprocesses are increasing productivity in the biopharmaceutical industry.

Read interview in BioPharma Asia

Contact

Discuss your manufacturing plans with us. Let us know your questions and requests. You will hear from us shortly.

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Cost Modelling of Bioprocesses by
Andrew Sinclair, Biopharm Services,
at the European Upstream & Downstream Forum 2016

Driving out costs from the manufacture of biologics is receiving greater attention within the biopharmaceutical industry. Modelling tools can help companies understand the impact of innovative bioprocessing technologies on process economics. Andrew Sinclair of Biopharm Services highlights how cost modelling successfully predicted that the adoption of single-use technologies by the industry would reduce biomanufacturing costs.

More about the Forum