Cell Culture Bioreactors
For Research and Development Work Through to Pilot and cGMP Manufacture
Sartorius Stedim Biotech supplies the widest range of cell culture bioreactors for research and development work through to pilot and cGMP Manufacture. Optimally suited for production of mAbs, vaccines, recombinant proteins, and in cell and gene therapy applications, the systems support many different types of cell lines and processes including batch, fed-batch, and perfusion | continuous processing. We deliver solutions for suspension as well as adherent microcarrier cultures, including those which require low shear and specialist mixing capabilities.
Our advanced microbioreactor (Ambr®) systems have become an industry-standard providing high throughput multi-parallel clone screening and process optimization solutions in a reproducible scale-down format to enable effective R&D at lower volumes. For larger scales, the trusted Biostat® product series includes single-use, autoclavable and in-situ sterilizable solutions. Classic stirred-tank design ensures seamless scale conversion to the Biostat® STR single-use bioreactor and also to stainless steel equipment for large-scale manufacturing.
Advanced analytical capabilities including online glucose and lactate measurement, off-gas measurement, and viable biomass/ cell density measurement allow predictive process modeling and control.
The demand for single-use materials increases rapidly, also for use in critical applications (see also Regenerative Medicine). Therefore, their robustness, performance, and compliance are crucial for process safety and economy. The polyethylene film (Flexsafe®) developed by Sartorius Stedim Biotech is used in bioprocessing bags for Biostat® RM and STR® to meet the most stringent customer needs.
Adopting a Platform Approach to Upstream Processing Increases the Speed to Clinic of New Biopharmaceuticals
Biopharmaceutical companies are reducing the time it takes for their products to reach the clinic by adopting platform processes. This white paper highlights technologies and responses to a key industry challenge - time to market - in order to continuously optimize upstream technologies. Sartorius has generated extensive data to demonstrate the scalability of the Cellca CHO expression system in our Biostat STR® bioreactor range from 50 L to 1000 L and in stirred-tank and rocking motion formats. Further topics are high throughput cell culture development techniques and testing of biosimilar molecules.