Sartorius Stedim Biotech has combined the high throughput screening capabilities of the ambr® 15 system, the simultaneous IgG titer and cell viability analysis of Cy-clone™ PLUS for determining “Top 3” cell line clones, and the GMP Master Cell Banking (MCB) services from BioOutsource. This integrated offering automates the selection of those cell lines that will perform best in production, due to ability of the ambr® 15 to predict large-scale bioreactor performance. Once selected Sartorius Stedim Biotech can provide you with high producing, stable and GMP-compliant MCBs in less time and with less effort, all from a single supplier.
Leading micro bioreactor system for cell line development and process optimisation
ambr®15 is an automated microscale bioreactor system that replicates classical laboratory scale bioreactors. The benchtop system comprises disposable micro bioreactor vessels, an automated workstation and user friendly software. ambr 15 offers automated parallel processing and control of 24 or 48 bioreactor experiments using just one operator. Designed to be installed in a standard laminar airflow biological safety cabinet for aseptic operation. ambr 15 provides efficient, consistent and scalable bioreactor experiments compared to classical laboratory bioreactors.
The fastest way to the best clones
The only solution that correlates IgG quantitation per cell with cell health and growth readouts in a single, cost-effective competition assay using IgG-capture beads, IgG fluorescent competing antibody, and a cell viability stain. Cy-Clone Plus provides pertinent data for clone selection—IgG concentration, IgG quantitation per cell, IgG quantitation per viable cell, cell density, and viability.
Fully characterized, well-documented, homogeneous master cell banks (MCB) and working cell banks (WCB) are critical attributes to mitigate risk and ensure safety and product quality of any biological product.
The traditional cell bank preparation culture process begins by thawing a cryopreserved vial of a research cell bank into shake flask cultures followed by successive, time-consuming, expansion steps to achieve the desired cell number prior to filling. These manipulations increase the risk of potential contamination of the cell bank production. BioOutsource and Sartorius Stedim Biotech have combined their expertise to develop an industry leading closed-system, single-use and fully cGMP compliant cell banking manufacturing process with comprehensive PAT options available.
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