Sartorius Stedim Biotech Release: New Paper On Automated, Single-use, High-Throughput Process Development

Presents data on how scientists at Merck are using the ambr® 250 system as a tool for rapid development of both cell culture bioprocesses and microbial fermentation

Cambridge, UK – September 29, 2015: Sartorius Stedim Biotech (SSB) today announced a new paper entitled, ‘Automated disposable small-scale bioreactor reactor for high-throughput process development: implementation of the 24 bioreactor array’ has been published in the respected, peer reviewed journal, Pharmaceutical Bioprocessing. The paper details how scientists at leading pharmaceutical firm, Merck are utilising the ambr® 250 automated mini bioreactor system to improve process development of both mammalian and microbial cell culture bioprocesses.

The paper describes how Merck have utilised the ambr 250 as a high through-put scale down model for process development. The results demonstrate the consistency of conditions in each ambr 250 single-use bioreactor across all 24 vessels, allowing for rapid execution of complex design of experiments (DOEs).

The paper also details how the system enabled one scientist to run 24 bioreactors in one experiment, which is up to four times faster than conventional approaches using 3L glass bioreactors. In addition, the use of pre-made sterile assemblies and single-use components greatly reduces set up and cleaning time compared with traditional glass bioreactors, thus improving both set-up and turnaround time.

In summary, the paper represents a powerful example of single-use bioreactor technology integrated with automation to provide a high throughput tool for a new era of rapid bioprocess development and optimisation.

To request free access to this paper, scientists should click the link: http://www.tapbiosystems.com/ambr250_webinar/reqpaper.asp

Mwai Ngibuini, ambr 250 Product Manager, at SSB commented: “Biologics and vaccine development continues to grow worldwide, with pipelines including monoclonal antibodies and novel scaffold approaches to engineer therapeutic proteins. These approaches require significant process development, complex multifactorial statistical experimentation and huge costs to develop process understanding of factors which impact product quality. Development of high-throughput bioreactor scale-down systems are crucial for satisfying new regulatory understanding of these processes.”

Ngibuini added: “This new paper published by Merck’s scientists shows the efficiency gains of automated high-throughput process development. Their data demonstrates that the ambr 250 technology is a scale down model that enables faster throughput of pipeline projects, therefore significantly increasing the upstream process development of protein-based therapeutics manufactured by microbial and cell culture processes.”

A profile of Sartorius Stedim Biotech

Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.”

Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,700 people, and in 2014 earned sales revenue of 683.5 million euros.

ambr® systems are designed and manufactured by TAP Biosystems (now part of the Sartorius Stedim Biotech Group) a leading global provider of automated cell culture and fermentation systems for life science research, development and production. ambr systems are widely used for cell line development and process optimisation at pharmaceutical, biotechnology and academic laboratories. They are proven to provide a reliable model and consistent scalability to a range of upstream processes.

Contacts:

Michaela McAdam,
Marketing Communications Manager, Sartorius Stedim Biotech (formerly TAP Biosystems)
Tel: +44 (0) 1763 227200
michaela.mcadam@sartorius-stedim.com

Dr Sue Pearson, Director, International Science Writer
Tel:+44(0)1462-635327
sue.pearson@internationalsciencewriter.com

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