Live monitoring of Cell Therapy Products, directly in a cell culture bag.
Chimeric Antigen Receptor (CAR) T-cell therapies are showing high response rates in patients worldwide, resulting in two approved products by the US Food and Drug Administration in 2017. T-cells from a patient are removed from the blood and engineered to express the CAR to reprogram the T-cells to target patients tumoral cells. (1)
In these autologous therapies, the challenges lay in the inherent variability in starting materials and the goal of maximizing product consistency while producing a safe, pure and potent product. These challenges require integration of strong product safety and quality controls in the manufacturing process, assuring the suitability of the final product. (2)
In CAR-T cell manufacturing, each handling or addition of reagents to the cell preparation generates a risk for error and for contamination that can possibly lead to the loss of a production run. A reliable solution consists of removal of open handling and implementing closed culture systems, where the cell manufacturing takes place in bags with closed tubing pathways and connections, maintaining a sterile environment.
Ovizio's patented technology, Double Differential Digital Holographic Microscopy (D3HM), is a quantitative imaging technique that allows cell monitoring in a continuous, label-free set-up. No need for sampling (eliminating the risk of contamination), staining, and waiting for results generated by an off-line counter or analyzer, therefore, results are available in nearly real-time and cover the length of the culture. The platform generates a holographic fingerprint based on 70 parameters for every cell that is imaged and feeds this data to a machine learning platform that can be trained to identify cells, and discriminate between cell types.
Fast and accurate, the algorithms automatically discriminate living from dead cells, count and give access to in-depth quality attributes and dynamic properties of your samples, and can also provide additional information on a single cell level
The iLine F allows real time in-process controls through OPC and has been intensively cross validated versus multiple cell counting counting methods.
(1) Towards a commercial process for the manufacture of genetically modified T cells for therapy, A D Kaiser, M Assenmacher, B Schröder, M Meyer, R Orentas, U Bethke & B Dropulic, Cancer Gene Therapy volume 22, pages 72-78 (2015)
(2) Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century, Rachel Haddock, MS, GlaxoSmithKline; Sheng Lin-Gibson, PhD, National Institute of Standards and Technology; Nadya Lumelsky, PhD, National Institute of Dental and Craniofacial Research, National Institutes of Health; Richard McFarland, PhD, MD, Advanced Regenerative Manufacturing Institute; Krishnendu Roy, PhD, Georgia Institute of Technology; Krishanu Saha, PhD, University of Wisconsin- Madison; Jiwen Zhang, PhD, GE Healthcare; Claudia Zylberberg, PhD, Akron Biotech, June 23, 2017
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