Global Milestone: First Stem Cell Drug Using Cytoniche's 3D FloTrix® Process Receives CDE IND Acceptance

Nov 16, 2023 07:20 CST Updated 07:20

Double Bioproduct

Developer of Anti-Tumor Gene Therapy Drugs

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On November 10, 2023, according to the public information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Huakan Bio's strategic partner ——Guangzhou Dabo Biological Products Co., Ltd. (hereinafter referred to as "Dabo Bio") has received acceptance for the IND application of its self-developed Class I biological product, "Human Umbilical Cord Mesenchymal Stem Cell Injection."(Application No.: CXSL2300769). It is reported that the indication for this application is Type II Diabetes.

This stem cell new drug adopts 3D FloTrix by Huakan Biotechnology.^®A series of products and processes for the large-scale three-dimensional culture, expansion, and preparation of cells have becomeThe First Stem Cell New Drug Accepted for IND Application Using a 3D Fully Enclosed, Large-Scale, and Automated Production Process。

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Support Stem Cell New Drug Application

The stem cell new drug declared by Guangzhou Dabo Biological Products Co., Ltd. differs from other stem cell new drugs that have been approved and entered the clinical stage in terms of cell CMC (Chemistry, Manufacturing, and Control).There are significant differences in the preparation process.。

Dabo Bio first adopts Huakan Bio 3D TableTrix^®Microcarriers and Lysate, 3D FloTrix^®Mesenchymal Stem Cell Serum-free Culture Medium and a Series of Automated Equipment Devices,The prepared 3D human umbilical cord mesenchymal stem cells are used for the clinical trial application of new stem cell drugs, laying a solid technical foundation for subsequent clinical trials and commercial-scale production.。

Huachao Bio 3D Fully Closed, Scalable, Automated Process for Stem Cell New Drug PreparationAccepted by CDE, marking 3D TableTrix^®Microcarriers, as raw materials for the production of cell therapy products, must ensure quality safety and controllable risks.; Processed by 3D FloTrix^®Mesenchymal stem cell products prepared by the process, theirStable production process and cell quality meet the basic standards for clinical application of stem cell therapy products and gain regulatory approval.。

Meet Different Cell Culture Needs

3D TableTrix^®Microcarriers provide an appropriate microenvironment for optimal cell growth and differentiation, better simulating the in vivo cell growth environment and complex intercellular interactions, with the ability to create tissue-like structures in vitro.Huachao Biotechnology can design customized 3D expansion culture processes for mesenchymal stem cells derived from different tissue sources, meeting various cell culture needs based on their growth characteristics.

With Huachao Bio 3D TableTrix^®Microcarrier-based, via 3D FloTrix^®Human umbilical cord mesenchymal stem cells prepared through a fully enclosed, large-scale, and automated process,Its quality has successively obtained verification reports from the National Institutes for Food and Drug Control (NIFDC) and authoritative third-party quality inspection agencies.。

NIFDC "Test Report"

Authoritative Third-Party "Test Report"

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At the same time, the "Quality Management Standards for Raw Materials Used in the Production of Cell Therapy Products" group standard was jointly drafted by multiple entities, led by the National Institutes for Food and Drug Control, including Beijing Huakan Biotechnology Co., Ltd. This marks Huakan Biotechnology as a leading enterprise in the field of 3D cell culture, with its independently developed...3D FloTrix^®Product series and processes meet the development trend of cell pharmaceuticals, leading the industry's innovative standards.。

Quality Management Standards for Raw Materials Used in the Production of Cellular Therapy Products

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About Dabo Bio

eMedClub

GuangGuangzhou Dabo Biological Products Co., Ltd. is an innovative drug research and development enterprise in China with a rich pipeline of drugs and independent innovation capabilities in the field of precision-targeted anti-tumor drugs.As a national high-tech enterprise and a specialized and innovative enterprise in Guangdong Province, Guangzhou Dabo Biological Products Co., Ltd. is committed to independent research and development, clinical research, and commercial production. Long-term relentless efforts have enabled Dabo Bio to continuously achieve impressive results in the field of anti-tumor drug research and development.

The company has always focused on forward-looking technology research and development as its core. It has built two provincial enterprise key laboratories (engineering laboratories) for anti-tumor drug research and development and one municipal enterprise key laboratory for gene therapy. Additionally, it has established five new drug research and development functional platforms.

The company has established an oncology drug development pipeline and a GMP production platform in compliance with international standards. Its cutting-edge core technologies enable the company to continuously develop new drugs. After more than 20 years of relentless efforts, while making in-depth vertical progress, the company also emphasizes horizontal expansion. It explores not only in the field of genetic engineering but also in cellular (including immune and regenerative cells) and protein-related biologics, forming a sustainable series of product lines.

AboutHuacan Bio

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Beijing Huakan BioThe technology company was established in 2018, led by Professor Yanan Du's research team from the School of Medicine at Tsinghua University, with Tsinghua University participating as a shareholder.The core technology is derived from the transformation of scientific and technological achievements at Tsinghua University and has received support and application from multiple national-level projects.

As a high-quality 3D cell manufacturing expert, Huachan Biotech provides a one-stop customized cell scale-up solution based on 3D microcarriers, creating an original 3D cell intelligent manufacturing platform. This achieves large-scale, automated, intelligent, and closed production of cell therapeutics and their derivatives, helping global clients establish the most advanced cell therapy production lines. After pioneering a 【hundred-million-level】 stem cell preparation process pipeline, the company is accelerating towards a 【billion-level】 capacity, committed to empowering the cell and gene therapy industry with 3D cell scale-up intelligent manufacturing technology to benefit more patients.

Huakan Bio has a 5,000-square-meter R&D and transformation platform, including 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 platform with a newly built 1,200L microcarrier production line. In addition, it has an international cooperation and technology application center of more than 2,000 square meters in Shanghai to continuously integrate technological innovation into the new formats of the global biotechnology industry.