Sartorius Stedim Biotech (SSB) has developed a fully integrated technology platform to meet the requirements of upstream bioprocessing.
It combines a high performance expression system along with with equipment and process control for the rapid development and scale-up of robust, high-titer commercial biopharmaceutical manufacturing processes.
"Biopharmaceutical manufacturers will be able to reach the clinic in 14 months by leveraging this new platform"
The company says the biopharmaceutical industry is facing a series of challenges that it must address for it to deliver safe and efficacious products to a market made increasingly competitive by the emergence 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.
The company says that 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 clients within just four 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 says it has integrated more than 100 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,” said Stefan Schlack, Stefan Schlack, Senior Vice President Marketing and Product Management Bioprocess Solutions at Sartorius Stedim Biotech.
