News | September 1, 2016

Sartorius Stedim Biotech Presents First Fully Integrated Upstream Platform

Source: Sartorius

Unique product and service portfolio extensively covers all steps from cell line development to commercial manufacturing processes

Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, has developed an innovative and fully integrated technology platform to meet the requirements of today’s upstream bioprocessing. It combines a top-performing expression system with outstanding equipment and process control for the rapid development and scale-up of robust, high-titer commercial manufacturing processes.

The biopharmaceutical industry is facing a series of challenges that it must address in order for it to deliver safe and efficacious products to a market made increasingly competitive by the emerge of biosimilar products. Companies must rapidly assess and then focus their investments on those drug candidates that have the greatest chance of being successful. To do this they must cut drastically early-stage development timelines and increase the speed with which they can reach the clinic.

The upstream technology platform, which combines a range of products and services that Sartorius Stedim Biotech has developed, addresses this challenge without compromising on product quality, process productivity or robustness. Biopharmaceutical manufacturers will be able to reach the clinic in 14 months by leveraging this new platform. The royalty-free CHO expression platform of SSB’s subsidiary Cellca delivers the titers required to meet companies’ cost of goods objectives. Cellca can establish a research cell bank for their clients within just 4 months. The automated ambr15 micro bioreactor system is capable of controlling 24 or 48 micro bioreactor experiments. The system accelerates clone selection and scales up readily to BIOSTAT® STR single-use bioreactors, which biomanufacturers have successfully implemented at pilot and GMP production scales. To reduce early stage development timelines still further, Sartorius Stedim Biotech has integrated more than one hundred off-the-shelf and pre-qualified assays from BioOutsource into its platform allowing the rapid testing and analysis of biosimilar products.

“Our upstream platform is currently unique on the market and addresses customers’ needs and challenges of the biopharma industry in an exceptional way. It connects outstanding process technologies and brings biology to single-use bioprocessing. We are therefore introducing a whole new level of efficiency in upstream processing,” stated Stefan Schlack, Stefan Schlack, Senior Vice President Marketing and Product Management Bioprocess Solutions at Sartorius Stedim Biotech.

About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted 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 has a global reach. The company employs approx. 4,200 people, and in 2015 earned sales revenue of 884.3 million euros.

Source: Sartorius