【Billion-Level Stem Cells Production】 On-site GMP Bootcamp Training Program was Successfully Held
- Categories:Company News
- Author:CytoNiche
- Origin:CytoNiche
- Time of issue:2023-09-20
- Views:160
(Summary description)CytoNiche Bio's inaugural "Billion-Level Stem Cell Production " bootcamp training program was successfully concluded at the CytoNiche’s Shanghai Center of Excellence (CoE) from August 15th to 22nd. This year, the bootcamp developed an interactive and immersive GMP setting to bring more than 20 technical elites from stem cell companies in China as well as, international participants. The bootcamp consisted of a mix of plenary training modules and lectures and interactive break-out sessions in smaller, more focused groups. The training was led by CytoNiche’s experts providing tips and feedback on scaling-up stem cells production and potential technical difficulties encountered by customers.
【Billion-Level Stem Cells Production】 On-site GMP Bootcamp Training Program was Successfully Held
(Summary description)CytoNiche Bio's inaugural "Billion-Level Stem Cell Production " bootcamp training program was successfully concluded at the CytoNiche’s Shanghai Center of Excellence (CoE) from August 15th to 22nd. This year, the bootcamp developed an interactive and immersive GMP setting to bring more than 20 technical elites from stem cell companies in China as well as, international participants. The bootcamp consisted of a mix of plenary training modules and lectures and interactive break-out sessions in smaller, more focused groups. The training was led by CytoNiche’s experts providing tips and feedback on scaling-up stem cells production and potential technical difficulties encountered by customers.
- Categories:Company News
- Author:CytoNiche
- Origin:CytoNiche
- Time of issue:2023-09-20
- Views:160
CytoNiche Bio's inaugural "Billion-Level Stem Cell Production " bootcamp training program was successfully concluded at the CytoNiche’s Shanghai Center of Excellence (CoE) from August 15th to 22nd. This year, the bootcamp developed an interactive and immersive GMP setting to bring more than 20 technical elites from stem cell companies in China as well as, international participants. The bootcamp consisted of a mix of plenary training modules and lectures and interactive break-out sessions in smaller, more focused groups. The training was led by CytoNiche’s experts providing tips and feedback on scaling-up stem cells production and potential technical difficulties encountered by customers.
In recent years, there have been numerous research achievements in stem cell therapy technology, but industrial development is still constrained by the quality and efficiency of stem cell production. "How to achieve closed, automated, and large-scale cell production" has become a challenging problem that the industry urgently needs to overcome.
To help many customers break through these bottlenecks, after five years of accumulation, CytoNiche Bio has introduced a[Billion-Level] stem cell production and preparation process. This process is based on original research products such as 3D TableTrix® microcarriers, 3D FloTrix® series automated bioreactors, and cell harvesting systems, establishing an automated, continuous, and closed billion-level stem cell GMP process pipeline.
By using this process to produce stem cell therapy products, the risk of contamination from open operations is eliminated, significantly reducing consumable, labor, and time costs during the cell production preparation process. While meeting the quality and safety standards for clinical applications of stem cells, it can also meet the demand for cell production in clinical applications and commercialization processes—achieving a billion cells in 13 days.
With numerous "achievements," CytoNiche Bio's 【Billion-Level Process】 has been highly appraised. By combining theoretical explanations with practical GMP operations, motivated participants now can be fully engaged and involved in learning the cells production process.
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CytoNiche Bio's technical application specialists started with laboratory construction planning, mainly explaining the working principles and operational process of equipment setup. Participants received one-to-one feedback from the application specialists regarding the actual GMP process leading to that a billion MSCs production in a single closed operation – from 5L to 15L scale moduli and followed by closed-system cell harvesting and packaging. Feedback from the participants was positive! CytoNiche would like to thank all the participants for dedicating their time and hands-on involvement in our stem cells production held in a 30m2 laboratory.
The hands-on training included the installation and parameter software settings of a series of equipment such as the vivaSPIN automated bioreactor, vivaPREP PLUS cell harvesting system, vivaPACK/FILL cell filling system, vivaEXO extracellular vesicle harvesting system, and the control operations during system operation. By learning and critical process parameters, participants had support from the our technical expert in a structured learning environment and streamlined experience to build on their foundational knowledge in the entire end-to-end GMP bioprocess and equipment deployment in GMP suite.
Existing customers gained further access to upskill and connect to our expertise in Q&A dialogues helping them to trouble-shoot pitfalls and master the key crucial points with technical details. These existing customers witnessed first-hand how to achieve fully closed production, effectively improve labor productivity, and complete the washing and packaging of a billion cells in a single batch.
Participants from mainland China, Taiwan, and Korea sharpen their skillsets, nurture their experiences and expertise in the realm of stem cells production. In particular, they not only witnessed the gentle degradation of microcarriers and the complete harvesting system process but also followed-through on the observed cell proliferation in continuous passages. In just four days, the cells grew more than 10 times whilst maintaining a 90% cells viability. The comprehensive results also included the large-scale harvesting of extracellular vesicles.
In addition, every participant gained a deeper understanding of CytoNiche Bio's 3D cell cultivation technology development, layout, and future plans through a visit to the CytoNiche Bio 3D Cell Smart Manufacturing Experience Platform. They took this opportunity to informally exchange industrial views, opinions, and trends regarding the future of smart cell factories.
Taking CytoNiche Bio's development process as an example, every participant was confident in the development and application prospects of cell and gene therapy and believed that CytoNiche shall continue to empower the cell and gene therapy industry with 3D cell scale smart manufacturing technology. Together, CytoNiche hopes to translate our advanced technology research and development, smart manufacturing platform and pillar into mature clinical treatment products for every patient’s benefit .
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