CytoNiche's 3D FloTrix® Billion-Level Process Receives Authoritative Third-Party Quality Certification
- Categories:Company News
- Author:CytoNiche
- Origin:CytoNiche
- Time of issue:2023-09-13
- Views:34
(Summary description)Creating innovative original research products, technologies, and processes to achieve a breakthrough in the "quality" and "quantity" of three-dimensional cell culture.
CytoNiche's 3D FloTrix® Billion-Level Process Receives Authoritative Third-Party Quality Certification
(Summary description)Creating innovative original research products, technologies, and processes to achieve a breakthrough in the "quality" and "quantity" of three-dimensional cell culture.
- Categories:Company News
- Author:CytoNiche
- Origin:CytoNiche
- Time of issue:2023-09-13
- Views:34
Recently, Beijing CytoNiche BioTech Co., Ltd. (hereinafter referred to as "CytoNiche"), at the request of a CDMO customer, sent umbilical cord mesenchymal stem cells prepared using CytoNiche's 3D FloTrix® billion-level process to Wuhan JiaChuang Biotechnology Co., Ltd. (hereinafter referred to as "Wuhan JiaChuang") for quality reassessment, and officially received their issued "Test Report" (No.检字<2023>012302052). This marks the first case in China where a continuous and closed production process has been used to prepare a batch of billion-level umbilical cord mesenchymal stem cells, certified through third-party quality reassessment.
Before this, the use of CytoNiche's three-dimensional culture technology (3D TableTrix® microcarriers and large-scale 3D FloTrix® vivaSIPIN bioreactors) for fully enclosed large-scale preparation of umbilical cord mesenchymal stem cells had also been certified by the China Food and Drug Testing Institute.
[Wuhan JiaChuang]
Wuhan JiaChuang Biotechnology Co., Ltd., founded in 2011, is a high-tech enterprise that integrates biotechnology services and research and development. It focuses on providing quality testing of various cells (including recombinant cells, stem cells, immune cells, etc.) and raw materials to pharmaceutical and bioproduct manufacturing companies and research institutions. They possess CMA and CNAS qualifications in this field and have obtained certifications for quality management systems (ISO 9001), environmental management systems (ISO 14001), and occupational health and safety management systems (OHSAS 18001). They can provide quality testing services for various stages of stem cell therapy product production in accordance with relevant regulations or guidelines, including basic biological property testing, microbiological safety testing, biological safety testing, and biological efficacy assessment.
[Inevitable Trend]
For larger-scale, commercialized production, automated and closed-cell expansion and harvesting systems are an inevitable trend in the development of cell therapy product manufacturing.
As early as 2017, the National Medical Products Administration (NMPA) issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)," which recommended the use of continuous and closed preparation processes to ensure product quality.
In 2021, the "Pharmaceutical Production Quality Management Specification - Cell Therapy Product Appendix" (Article 11) recommended the use of closed systems for cell product production.
In 2023, the "Pharmaceutical Research and Evaluation Technical Guidelines for Human Stem Cell Products (Trial)" reiterated the recommendation to use closed equipment to reduce environmental exposure during production.
[CytoNiche's Billion-Level Stem Cell Preparation ]
Based on the 3D TableTrix® microcarriers and 3D FloTrix® cell culture technology, CytoNiche, with the assistance of a series of cell culture, harvesting, and filling equipment, has constructed a groundbreaking "billion-level" stem cell production plan. The entire production process employs a fully enclosed, automated process that allows for real-time cell counting and quality monitoring. Cell amplification cultivation can reach billions within 13 days, and the final cell preparations comply with strict quality control and repository standards.
Furthermore, CytoNiche can design customized three-dimensional expansion and cultivation processes for mesenchymal stem cells from different tissue sources to meet various cell culture requirements, achieving a breakthrough in both "quality" and "quantity" of cell production.
[3D FloTrix® Cell Technology Platform]
The 3D FloTrix® cell technology platform by CytoNiche, built on the billion-level cell preparation process, offers several advantages in stem cell CMC (Chemistry, Manufacturing, and Controls) processes:
For specific cell types and process requirements, it can achieve continuous and closed production processes from cell seeding, cultivation expansion to cell harvesting and filling under C-level environments. This enhances batch cell yield significantly, reduces production costs, and mitigates the risk of batch-to-batch quality variability that results from repetitive cell production.
According to Article 36 of the "Pharmaceutical Production Quality Management Specification - Cell Therapy Product Appendix," "closed systems should be used for cell culture, and different batch products can be cultured and stored in the same production operation room or the same incubator." By using CytoNiche's 3D FloTrix® dynamic cultivation process, multiple batches of cells can be expanded and cultivated simultaneously in the same production operation room, efficiently utilizing clean space while ensuring low contamination risk.
The 3D FloTrix® vivaSPIN automated bioreactor equipment series includes the 3D FloTrix® CELL PRO live cell online monitoring system, which provides real-time and accurate monitoring of live cell status, and the PECALS® control system, which accurately executes automated programs, supports remote parameter control, and provides real-time data recording with user permissions and parameter settings based on users' needs. The cell data is comprehensive and traceable.
Using the 3D FloTrix® vivaPREP PLUS cell harvesting system for large-scale, one-time cell harvesting can ensure the uniform quality of the final cell product, reducing batch-to-batch variations during cell preparation and ensuring the quality and safety of cell therapy products.
[Additional Information]
ions that have obtained certification from the CMA can use the CMA seal on test reports. These reports have legal validity and can be used for product quality evaluation, achievements, and legal identification.
CNAS (China National Accreditation Service): CNAS qualification is a universally recognized accreditation with the CNAS logo representing compliance with international requirements.
3D TableTrix® Microcarriers:
3D TableTrix® microcarriers provide an ideal microenvironment for optimal cell growth and differentiation. They better mimic the cell growth environment and complex cell-tissue interactions in the human body and have the ability to create tissue-like structures in vitro. The quality of umbilical cord mesenchymal stem cells prepared with 3D TableTrix® microcarriers meets the quality control standards for stem cell preparations outlined in the "Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations." All three-dimensional expansion process parameters have been repeatedly validated to ensure the stability of stem cell preparation processes for different cell types.
[CytoNiche's Support Services]
▷ If you are conducting research related to projects using 3D TableTrix® Microcarrier and need to submit applications to the FDA such as Investigational New Drug (IND) or New Drug Application (NDA), you can contact the relevant sales department to apply. CytoNiche Biotech will provide you with an authorization letter that allows the FDA to directly review the technical content of the DMF involved during drug application review, helping to expedite the FDA review process.
▷ If you're interested in CytoNiche Biotech's 3D TableTrix® Microcarrier, you can also scan the code to apply for a trial.
【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.
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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