Cell therapy is a broad term which encompasses the application as a therapeutic of various cell populations, usually stem cells. These cells include adult stem cells or specific progenitor cells derived from adult populations, or differentiated from embryonic stem cells (ESC) or induced pluripotent stem cells (iPSC) for therapeutic use. Mesenchymal stem cells are the most commonly used class of stem cells given their extensive differentiation capacity. There is a predominance of MSC derived cell therapies within the current pool of cell therapy clinical trials, but other cell lineages are also being investigated for new indications.
MSCs have been used in the clinic for over twenty years and offer great hope to patients suffering from disorders such as diabetes, myocardial infarction (MI), and acute immune disorders such as GvHD. The fundamental manufacturing challenges associated with the production of MSCs, such as the need to scale-up of anchorage-dependent cells and harvest, wash and formulate them without losing viability, are illustrative of production challenges of other cell therapies.
Sartorius offers a range of technologies for your cell therapy development and manufacturing process. The Ambr® microbioreactor systems are ideal for process development and optimization, and our expanding portfolio of products for both development and production scales will aid in ensuring commercial success. Our unique bioreactor technologies are fully scalable from the benchtop Ambr® systems through to pilot and commercial scale Biostat STR® production bioreactors, which offer single use solutions from 50L all the way up to 2000L. Sartorius’ Ksep® patented single-use continuous centrifugation technologies can be used to wash, concentrate and perform buffer exchanges on cells after harvest from bioreactor.
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The Ambr®15 Workstation is designed to fully automate the use of disposable Ambr® (10 – 15mL working volume) microbioreactors. With the capacity to control up to 24 or 48 reactors, ambr has been designed to provide a low cost, stirred, disposable microscale alternative to running experiments in conventional bioreactors. This technology provides improved efficiency of cell culture processing with automated experimental set up and sampling, requiring less labor and laboratory space, and no need for system down-time for cleaning and sterilization. The system has been proven to be a vital process development tool within the regenerative medicine industry and is currently being used for suspension adaptation and microcarrier applications, as well as media optimization studies.
The Biostat STR® single-use bioreactor family is the ideal platform for your flexible manufacturing facility, supporting fed-batch and continuous processes. Sartorius single-use Flexsafe STR® bags offer low contamination risk and are available in working volumes ranging from 12.5 to 2000L ideally suited for scale-up, pilot runs and commercial production of cell therapies. Notably, our Flexsafe STR® bags can be outfitted with integrated single-use sensors for pH, DO and Viamass, enabling control and monitoring of these critical cell culture parameters online. The Biostat STR® is a vital piece of equipment for suspension and microcarrier cultivation of stem cells.
The Ksep® systems are a scalable single-use centrifugation platform that are ideal for the processing of cell therapies. The technology uses opposing centrifugal and fluid flow forces to retain cells or microcarriers in a concentrated fluidized bed under a continuous flow of media or buffer. Cells experience very low shear forces, ensuring their integrity and viability in a culture-like environment. This instrument is ideal for microcarrier and particulate removal or cell processing for final formulation.
iQUE Screener PLUS
With the ability to multiplex cellular phenotype and function from a mix of cell types in a single well, the iQue Screener PLUS is the ideal solution for delving into the complexities and nuances of the immune system, including changes in signaling molecules, cytokine secretion, and measures of cellular health. By employing sophisticated automation and rapidly sample delivery, the iQue Screener PLUS converts the low throughput, time consuming flow cytometry approach into a truly high throughput method: analyze 96-well plates in less than five minutes and 384-well plates in under 20 minutes. The iQue Screener PLUS can sample as little as 1 µL from each well, allowing assay volumes to be miniaturized down to 9 µl, saving reagent costs and conserving limited patient samples. The powerful purpose-built ForeCyt data analysis and visualization software makes short work of large combinatorial datasets for the fastest time to answer and decision making.