12.06.16
Sartorius Stedim Biotech (SSB) has developed a fully integrated technology platform designed to meet the requirements of today’s upstream bioprocessing. It combines an expression system with equipment and process control for the rapid development and scale-up of robust, high-titer commercial manufacturing processes.
To overcome some of the challenges the biopharmaceutical industry faces, companies must quickly assess and then focus their efforts on the drug candidates that have the greatest chance to succeed. In order to accomplish this, companies must drastically cut early-stage development timelines and increase the speed to reach the clinic.
With the upstream technology platform, which combines a range of Sartorius products and services, biopharma manufacturers may reach the clinic in as little as 14 months, according to the company. The royalty-free CHO expression platform of SSB’s subsidiary Cellca can deliver the titers required to meet cost of goods objectives. Cellca can establish a research cell bank for their clients within 4 months and 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 help further reduce early stage development timelines, Sartorius 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,” said Stefan Schlack, senior vice president marketing and product management Bioprocess Solutions at Sartorius Stedim Biotech.
To overcome some of the challenges the biopharmaceutical industry faces, companies must quickly assess and then focus their efforts on the drug candidates that have the greatest chance to succeed. In order to accomplish this, companies must drastically cut early-stage development timelines and increase the speed to reach the clinic.
With the upstream technology platform, which combines a range of Sartorius products and services, biopharma manufacturers may reach the clinic in as little as 14 months, according to the company. The royalty-free CHO expression platform of SSB’s subsidiary Cellca can deliver the titers required to meet cost of goods objectives. Cellca can establish a research cell bank for their clients within 4 months and 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 help further reduce early stage development timelines, Sartorius 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,” said Stefan Schlack, senior vice president marketing and product management Bioprocess Solutions at Sartorius Stedim Biotech.