Recent advances in cellular immunotherapies are providing new and exciting treatments in the fight against difficult-to-treat forms of cancer. These new therapies, such as patient specific (autologous) Chimeric Antigen Receptor T-cells (CAR-T) and T-Cell Receptors (TCR) also bring with them new challenges for scalable and reproducible commercial production. Due to the nature of autologous cellular immunotherapies, the high variability of incoming patient material requires an increased focus on process analytics, robust and stable single-use consumables, and the implementation of automation to improve process control.
Sartorius provides the cellular immunotherapy industry with a range of scalable single-use production technologies. These tools range from the initial media supply and preparation, to viral vector transduction and cellular expansion, on to the downstream processing steps including harvest, wash, and concentration of the cells. Sartorius offers a variety of analytical technologies which allow for the support of the industry’s clinical and commercial production needs. An enhanced characterization of the individual therapy ensures the safety of the cellular immunotherapy products and the control of the production process.
BIOSTAT® RM 20/50 and BioPAT® ViaMass
The BIOSTAT® RM 20/50 is a single-use, rocking motion bioreactor that is cGMP compliant and makes use of our robust Flexsafe® film to provide superior quality, cell growth, and assurance of supply. BIOSTAT® RM bioreactors accommodate bag sizes ranging from 1L to 50L nominal volumes, with the option for either single or twin rocking bases per tower to allow for reduction of required footprint in the lab. Cellular immunotherapy manufacturers can use the BIOSTAT® RM 20/50 with our new BioPAT® Viamass single-use biomass sensor for the non-invasive measurement of viable biomass. The BioPAT® Viamass provides a significant increase of in-process data collection and real time decision making. The real-time, in-situ measurement of viable biomass allows for highly variable patient material to be monitored during the expansion phase without destructive sampling.
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.
Microsart® ATMP Mycoplasma
The Microsart® ATMP Mycoplasma kit is a real-time PCR-based technology that allows for fast and easy detection of contaminating mycoplasma species in only 3 hours. Sartorius designed this kit especially to test for mycoplasma contamination in advanced therapy medical products (ATMP), such as cell-based therapeutics. The fast detection time provided by the Microsart® ATMP kits is critical for products with short shelf life, such as cellular immunotherapies. The Microsart® ATMP Mycoplasma kit has been validated according to EP 2.6.7 in combination with EP 2.6.21 with respect to the detection limit for all listed Mycoplasma species.