New Product Application | Facilitating the Production and Preparation of [10 Billion] Stem Cells
- Categories:Company News
- Author:CytoNiche
- Origin:CytoNiche
- Time of issue:2023-03-16
- Views:0
(Summary description)The new arrival of 3D FloTrix® vivaPREP PLUS Cell Harvesting System facilitates a new breakthrough in the process, thus realizing the production and preparation of a single-batch [10 billion] stem cel
New Product Application | Facilitating the Production and Preparation of [10 Billion] Stem Cells
(Summary description)The new arrival of 3D FloTrix® vivaPREP PLUS Cell Harvesting System facilitates a new breakthrough in the process, thus realizing the production and preparation of a single-batch [10 billion] stem cel
- Categories:Company News
- Author:CytoNiche
- Origin:CytoNiche
- Time of issue:2023-03-16
- Views:0
In recent years, the research and application of stem cells has become an important measure of a country’s life science and medical development, and the research on stem cell transformation is also one of the key national strategic projects in the “14th Five-Year Plan”. With the deepening of relevant research, more market development space has been derived from various links of the whole stem cell industry, but China is still faced with lack of technological innovations in the development of the stem cell industry.
The 3D cell intelligent manufacturing platform, originally created by CytoNiche, has successfully built a “large-scale customized amplification process of cells” by utilizing the transformation results of core technologies such as 3D microcarriers and bioreactors.
The new arrival of 3D FloTrix® vivaPREP PLUS Cell Harvesting System facilitates a new breakthrough in the process, thus realizing the production and preparation of a single-batch [10 billion] stem cells.
The 3D FloTrix® vivaPREP PLUS is featured with:
✔ Fully closed and automated operation ✔ Continuous flow rinsing technology ✔ Disposable sterile consumables ✔ Compliance with GMP traceability |
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[Case Sharing]
The 3D FloTrix® vivaPREP PLUS Cell Harvesting System facilitates the large-scale culture process (cell passage and preparation harvesting) of stem cells.
3D Breeding
Inoculate 2×108 UC-MSCs and proper amount of 3D TableTrix® microcarriers W01 and 3D FloTrix® mesenchymal stem cell serum-free medium (referred to as serum-free medium) in a 5L 3D FloTrix® vivaSPIN bioreactor. Start intermittent inoculation mode for 6 hours and then change to constant speed cell culture mode.
Cell Passage
✦ As the cells are cultured, discharge the culture supernatant in the 5L 3D FloTrix® vivaSPIN bioreactor, add 3D FloTrix® Digest lysate, lyse the microcarrier in-situ and harvest the cell suspension.
✦ Carry out cell concentration and washing using the 3D FloTrix® vivaPREP PLUS Cell System;
① Prepare one set of consumables package in advance (including several main consumables + liquid storage bags). Fill 1L of cell suspension, 1L of normal saline and 0.5L of serum-free medium into the reservoir bag of the consumable package.
② Weld a sterile tubing welder to the main consumables to complete the concentration, washing and resuspension of the cell suspension in a fully closed manner.
③ Start the equipment to enter the self-inspection and installation procedure of the consumables package, and complete the installation of the consumables package.
④ Connect the cell sample bag, lotion bag and resuspension bag to the main consumables of the equipment. Set the parameters according to the experimental requirements.
⑤ After operation of the equipment, sample and count, resuspend and dispense the cell suspension as required. Take away seed cells using a sterile tubing welder.
Amplification Culture
Inoculate 2×109 UC-MSCs prepared by the 3D FloTrix® vivaPREP PLUS Cell Harvesting System into two 15L 3D FloTrix® vivaSPIN bioreactors with 3D TableTrix® microcarrier suspension respectively, and supplement serum-free medium. Start the cell mode, culture them for 4-5 days, and set the parameters for replacement and culture in advance.
Cell Preparation Harvesting
Carry out the concentration, washing and harvesting of 1×1010 cells by using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System and manual harvesting. The cells harvested in two ways (the materials are prepared in the following table) are tested for cell quality as follows.
Test Results
1. 1×1010UC-MSCs were harvested using the 3D FloTrix® vivaPREP PLUS Automated Harvesting System and Manual Harvesting, with the recovery rate as high as 95% by automated harvesting while 86% by manual harvesting; the viability of harvested cells reached over 95%.
Figure 1: Comparison of recovery rate and viability of cells harvested by two modes
2. UC-MSCs harvested automatically using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System were analyzed for cell phenotype, meeting the industry quality control standards.
3. UC-MSCs harvested automatically using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System were analyzed for lysate and microcarrier residues, meeting the quality control standards of the National Institute for Food and Drug Control.
Figure 2: Comparative analysis of lysate and microcarrier residues
4. UC-MSCs harvested automatically using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System showed sound cell proliferation after 2D and 3D culture.
5. UC-MSCs harvested automatically using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System demonstrated satisfied tri-lineage differentiation potential of chondrogenesis, osteogenesis and adipogenesis.
Figure 3 Testing of tri-lineage differentiation of UC-MSCs
6. UC-MSCs harvested automatically using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System were tested for tumorigenicity and no clone formation was found, indicating that the cells are not tumorigenic.
Figure 4 Tumorigenicity testing of UC-MSCs
7. Telomerase activity:
The Ct value of GAPDH, the internal reference, was between 17±3, and that of TERT gene, the catalytic subunit of telomerase, was ≥35 with no obvious amplification curve. No telomerase activity was detected in this sample, and the result was negative.
Karyotype analysis:
MSCs harvested automatically using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System were karyotypically normal.
Figure 5 Test results of telomerase (left) and karyotype (right) of UC-MSCs
[Conclusion]
1×1010 UC-MSCs are harvested using the 3D FloTrix® vivaPREP PLUS Cell Harvesting System:
✦ Cost, space and manpower: save 30% cost, 80% space and 90% manpower.
✦ Recovery rate and viability: both the recovery rate and viability of cells are as high as 95% with good uniformity, thus avoiding losses caused by improper human operation.
✦ Cell phenotype\residue analysis\proliferation ability\tri-lineage differentiation\tumorigenicity\telomerase activity\karyotype analysis: the quality of harvested UC-MSCs meets the industry quality control standards.
As large-scale production and preparation of stem cells is the cornerstone of the transformation and application of research results as well as the realization of industrial development, its related technology, capacity, quality and cost are more important measure of consideration.
Based on the core technology products such as 3D TableTrix® Microcarrier, 3D FloTrix® Automated Bioreactor and Cell Harvesting System, and combined with 3D FloTrix® Dynamic Culture Process, CytoNiche not only meets the demand for cell yield in the process of clinical application and commercialization of stem cell products, but also avoids the contamination risk caused by the open operation, and significantly reduces the cost of consumables, manpower and time in the process of cell production and preparation. In addition, harvesting a large number of cells at one time can better ensure the quality uniformity of the final products, reduce the differences across batches in the process of cell preparation, and ensure the quality and safety of cell therapy products.
For any questions or needs about this product, please scan the QR code or dial our hotline:400-012-6688.
Any of your questions or needs will be addressed by our technical experts.
【CytoNiche】
Beijing CytoNiche Biotechnology Co., Ltd. was established by the research team of Professor Du Yanan from Tsinghua University School of Medicine, and was jointly established by Tsinghua University through equity participation. The core technologies were derived from the transformation of scientific and technological achievements of Tsinghua University. CytoNiche focuses on building an original 3D cell "smart manufacturing" platform, as well as providing overall solutions for the 3D microcarrier-based customized cell amplification process.
CytoNiche's core product, 3D TableTrix® Microcarrier Tablet (Microcarrier), is an independent innovation and the first pharmaceutical excipient grade microcarrier that can be used for cell drug development. It has obtained the certificate of analysis from relevant authoritative institutions such as National Institutes for Food and Drug Control, and obtained 2 qualifications for pharmaceutical excipients from the National Medical Products Administration (CDE approval registration number: F20210000003, F20200000496). Moreover, the product has obtained the DMF qualification for pharmaceutical excipients from U.S. FDA (DMF: 35481).
Products and services of CytoNiche can be widely used in the upstream process development of gene and cell therapy, extracellular vesicles, vaccines, and protein products. At the same time, it also has broad prospects for applications in the fields of regenerative medicine, organoids, and food technology (cell-cultured meat, etc.).
Our company has a R&D and transformation platform of 5,000 square meters, including a CDMO platform of more than 1,000 square meters, a GMP production platform of 4,000 square meters, and a new 1200 L microcarrier production line. The relevant technologies have obtained more than 100 patents and more than 30 articles about the technologies in international journals have been published. The core technology projects have obtained a number of national-level project support and applications.
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