Mesenchymal stromal or stem cell (MSC) workflow for efficient clinical translation: from automated GMP-compliant cell manufacturing to standardized phenotyping

DATE:  June 23, 2020

TIME:  10:00am PT

Human mesenchymal stromal or stem cells (MSCs)-based immunomodulation treatment has been proposed as a suitable therapeutic approach for many diseases, such as COVID-19 disease. Several clinical trials have been started, and preliminary data hold great promise for clinical use and cell therapy for this severe disease. To facilitate efficient clinical translation, we developed an automated GMP-compliant cell manufacturing procedure using the integrated cell processing platform CliniMACS Prodigy®, which increases the level of process standardization and product safety. In this new adherent cell culture (ACC) system, sample cells are processed in a closed system, including automated density gradient centrifugation in case of human bone marrow sample, feeding, replating, expanding, and harvesting procedures. Clinical applications of MSCs for spine and joint pain needs only small amount stem cells injected locally. However, for systemic illness such as COVID-19, millions of cells are needed for IV inject. Our xeno-free MSC-Brew GMP Medium, following the recommendations of USP <1043> on ancillary materials, enables efficient isolation and expansion of MSCs from different tissue sources including human bone marrow, adipose tissue, and umbilical cord. Together with the ACC system,  over 200 million MSCs can be generated from single donor in just 14 days. Cultured MSCs need to go through strict quality control before any clinical applications. Our new MSC phenotyping kit, including 3 positive and 5 negative MSC markers based on ISCT standard, facilitates standardized and reliable phenotyping of cultured human MSCs from different tissue sources. The high-purity recombinant engineered antibodies (REAfinity™) in the kit ensures high lot-to-lot consistency and reproducible results in flow cytometry.  

Learning objectives:

• Discuss GMP grade serum-free and xeno-free Medium for efficient MSCs expansion from different tissue resources
• Discuss Automated and closed Adherent Cell Culture (ACC) System for GMP scale MSC production
• Discuss Standardized and reliable phenotyping of cultured MSCs

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