Intensified Processing for Biopharmaceutical Manufacturing
Technologies That Enable Continuous Production Throughout the Process
Continuous processing in biomanufacturing has the potential to increase production capacity, reduce costs and improve biopharmaceutical product quality. Sartorius Stedim Biotech is collaborating with leading biopharmaceutical companies as they intensify their bioprocesses. With these experiences, we are supporting clients seeking to implement continuous manufacturing operations within their facilities through the provision of technologies, services, insight and expertise.
Making Downstream Processing Continuous and Robust
In a virtual roundtable, BPI has invited several advisors, end users and supplier companies to comment on a discussion on continuous downstream processing. Miriam Monge, Sartorius Stedim Biotech, spoke about how process intensification in upstream has led to an increased footprint in downstream processing amongst other topics.
An Interview on Intensifying Upstream Cell Culture Processes
Watch Dirk Mueller talk about the intensification of upstream cell culture processes. An interview by Miriam Monge at ESACT 2019 in Copenhagen.
Intensified Upstream Processing
Process Analytical Technologies (PAT) can play an important role in enabling continuous bioprocessing. They help maintain these processes within a steady state. Authors from Sartorius discuss some of the challenges the industry faces in implementing continuous biomanufacturing and how we are addressing them with PAT tools such as the BioPAT® Viamass and the BioPAT® SIMCA-online in the following article: View Publication
Single-Use and Intensified Processing in Commercial Biomanufacturing
BPI TV interviews, Biotech Week 2018, Boston, MA: Miriam Monge and Gerben Zijlstra, Sartorius Stedim Biotech, in discussion with Dan Stanton, Editor of Bioprocess Insider
Bioprocess Intensification - Fast, flexible and efficient solutions
Published as a part of the BioProcess International supplement this compilation of articles details how our experts characterize “process intensification” and how end users can transition toward an increased safety and economic sustainability of continuous processing.
Integrated tools for upstream process intensification: part I
Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility.
Sartorius Takes a Single-Use Approach to Derive Value from Biomanufacturing
In a seminar organized by Sartorius in San Francisco four critical issues the biotech industry is currently facing were examined: a pressing need for cost reduction; the importance of flexibility in the design of facilities; meeting the demands of speed to the clinic through development and tech transfer; and precise measurement of product quality in order to meet the demands of the FDA and other agencies.
Cell Retention Technology
The kSep® centrifuge is a patented, highly versatile technology from Sartorius that biomanufacturers can use for either the optimized harvesting of cell culture supernatant or, alternatively, viable cells. Engineers use the technology for cell retention during intensified cell cultures for recombinant protein production, the removal of cells or micro-carriers during vaccine production or the harvesting of cells during cell and gene therapy manufacturing.
Inside the chambers of the kSep®, cells are maintained within a fluidized bed that is established through the balance of centrifugal and liquid flow forces preventing cell damage and host cell protein release. The fluidized bed allows soluble products to be separated easily from cells with a short, low-volume wash to maximize recovery. When harvesting viable cells, the settings of the kSep® can be adapted to remove dead cells and debris from viable cells in the fluidized bed. The resultant high viablility culture can either be harvested, returned to the same bioreactor or even be used to inoculate a new bioreactor, depending on the application.