Global First Stem Cell Drug Using HuaKan Bio's 3D FloTrix® Process Receives CDE IND Acceptance
CytoNiche
3D Cell Technology Products and Services Provider
On November 10, 2023, according to public information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, CytoNiche’s strategic partner—Guangzhou Dabo Biological Products Co., Ltd. (hereinafter referred to as “Dabo Bio”) has had its Investigational New Drug (IND) application for the Class I biological product “Human Umbilical Cord Mesenchymal Stem Cell Injection,” independently developed by the company, accepted for review.(Application No.: CXSL2300769). It is reported that the indication applied for in this submission is type 2 diabetes.
This novel stem cell drug utilizes CytoNiche’s 3D FloTrix.®Its product series and manufacturing process enable large-scale 3D cell culture expansion and preparation, making it the first stem cell new drug whose IND application was accepted based on a fully closed, large-scale, automated 3D production process.
Supporting IND Applications for Novel Stem Cell Therapies
Dabo Biologics’ Investigational New Drug (IND) Application for a Stem Cell Therapy, in Comparison with Other Approved Stem Cell Therapies That Have Entered Clinical Trials, Regarding Cell CMC (Chemistry, Manufacturing, and Controls)Significant Differences in Manufacturing Processes。
Dabo Biotech Adopts CytoNiche’s 3D TableTrix for the First Time®Microcarriers and Lysis Buffer, 3D FloTrix®Serum-Free Culture Medium for Mesenchymal Stem Cells and Series of Automated Equipment Devices,The prepared 3D human umbilical cord-derived mesenchymal stem cells are used for the investigational new drug (IND) application, laying a solid technical foundation for subsequent clinical trials and commercial-scale production.
CytoNiche’s Novel Stem Cell Drug Prepared via a 3D Fully Closed, Scalable, and Automated Manufacturing ProcessAcceptance by the CDE marks 3D TableTrix®Microcarriers, as raw materials for the production of cell therapy products, ensure quality safety and controllable risks.；via 3D FloTrix®human mesenchymal stem cell products prepared by a manufacturing process, whoseProduction process stability and cell quality meet the basic standards for clinical application of stem cell therapy products, gaining regulatory approval.
Meeting Diverse Cell Culture Needs
3D TableTrix® Microcarriers provide an optimal microenvironment for cell growth and differentiation, better simulating the in vivo cellular milieu and complex intercellular interactions, while enabling the formation of tissue-like structures in vitro.CytoNiche can design customized 3D expansion culture processes for mesenchymal stem cells based on the growth characteristics of different tissue sources, meeting diverse cell culture needs.
CytoNiche's 3D TableTrix®Microcarrier-based, via 3D FloTrix®Human umbilical cord-derived mesenchymal stem cells prepared through a fully enclosed, scalable, and automated manufacturing process,Its quality has been successively verified by the National Institutes for Food and Drug Control (NIFDC) and authoritative third-party quality testing agencies.
NIFDC “Test Report” Authoritative Third-Party “Test Report”
Meanwhile, led by the National Institutes for Food and Drug Control (NIFDC), Beijing Huakan Biotechnology Co., Ltd. (CytoNiche) and other organizations jointly drafted the group standard “Good Manufacturing Practice for Raw Materials Used in the Production of Cell Therapy Products,” marking CytoNiche, as a leading enterprise in the field of 3D cell culture, its independently developed3D FloTrix®The product series and manufacturing processes align with the development trends in cell-based pharmaceuticals, setting a benchmark for industry innovation.
《Good Manufacturing Practice for Raw Materials Used in the Production of Cell Therapy Products》
About CytoNiche
Beijing Huakan Biotechnology Co., Ltd. (CytoNiche) was established in 2018, founded under the leadership of Professor Ya-Nan Du’s research team from the School of Medicine at Tsinghua University, with Tsinghua University participating as a co-founder and shareholder. Its core technologies stem from the commercialization of scientific and technological achievements at Tsinghua University and have received support and application through multiple national-level projects.
As a leading expert in high-quality 3D cell manufacturing, CytoNiche provides one-stop, customized total solutions for large-scale cell expansion based on 3D microcarriers. The company has developed an original 3D intelligent cell manufacturing platform that enables scalable, automated, intelligent, and closed production of cell-based therapeutics and their derivatives, thereby helping global clients establish state-of-the-art cell therapy production lines. Having pioneered a stem cell preparation process pipeline at the [ten-billion level], CytoNiche is accelerating its advancement toward the [hundred-billion level], committed to empowering the cell and gene therapy industry with 3D large-scale intelligent cell manufacturing technology to benefit more patients.
CytoNiche boasts a 5,000-square-meter R&D and translational platform, which includes a CDMO service platform of over 1,000 square meters focused on 3D cell intelligent manufacturing and micro-tissue regenerative medicine therapeutic products, as well as a 4,000-square-meter GMP production facility with a newly built 1,200L microcarrier production line. Additionally, it has established an International Cooperation and Technology Application Center of over 2,000 square meters in Shanghai, continuously integrating technological innovation into the new landscape of the global bioindustry.
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About Dabo Bio
Guangzhou Dabo Biopharmaceuticals Co., Ltd. is an innovative drug R&D enterprise in China with a rich pipeline and independent innovation capabilities in the field of precision targeted anti-tumor drugs. As a national high-tech enterprise and a specialized, refined, distinctive, and innovative enterprise in Guangdong Province, it is committed to independent R&D, clinical research, and commercial production. Years of relentless efforts have enabled Dabo Biopharmaceuticals to achieve remarkable success in the field of anti-tumor drug development.
The company has always prioritized the research and development of forward-looking technologies. It has established two provincial-level key enterprise laboratories (engineering laboratories) for anti-tumor drug R&D, one municipal-level key enterprise laboratory for gene therapy, and five functional platforms for new drug development.
The company has established an international-standard pipeline for anti-tumor drug development and a GMP-compliant manufacturing platform. Its mastery of cutting-edge core technologies enables the continuous development of new drugs. Through more than 20 years of sustained efforts, the company has pursued both vertical deepening and horizontal expansion. It has not only made significant strides in genetic engineering but also actively explored and cultivated areas related to cell-based (including immune and regenerative cells) and protein-based biologics, thereby forming a sustainable portfolio of product lines.