【August 8, 2022】

Beijing CytoNiche Biotechnology Co., Ltd. (hereinafter referred to as "CytoNiche") embraced a milestone in its course of development: CytoNiche 3D Cell Intelligent Manufacturing and Regenerative Medicine Center - 3D FloTrix® Cell CDMO Platform had been officially set up, and the headquarters had come into service after expansion. At the same time, the kick-off meeting of the "Biological Manufacturing and Regenerative Medicine Forum" was also held on the same day.

The opening ceremony of "3D Cell Intelligent Manufacturing and Regenerative Medicine Center - 3D FloTrix® Cell CDMO Platform" was held at the new site of CytoNiche after expansion, which is also the former incubation center in Zhongguancun, Beijing.

【Guest Speech】

 Welcoming speech from Professor Du Yanan of Tsinghua University, Chief Scientist of CytoNiche:

Fellow leaders and experts, thank you very much for your presence and valued guidance. CytoNiche was founded in 2018, halfway through the 13th Five-Year Plan. During the 13th Five-Year Plan, CytoNiche successfully accomplished China's first major research and development project of automated large-scale culture of stem cells. We highly appreciate the support from the government and the guests who are here today. In the future, we will be committed to making breakthroughs concerning the industry "bottleneck" problems and serving the needs of more patients.

Speech from Academician Chen Xiangmei, Academician of Chinese Academy of Engineering, Honorary Chief of Nephrology Department, national key discipline of the Chinese PLA General Hospital, and Director of National Clinical Research Center for Kidney Disease:

The technologies of CytoNiche take root in the transformation of scientific research achievements of Professor Du Yanan's team at Tsinghua University. CytoNiche has become an important player in the international cell industry by leading the way in overcoming the difficult challenges for automated large-scale manufacturing of cells in China. We look forward to CytoNiche's efforts in integrating technologies with clinical practices to solve the world's cutting-edge problems and lead the cause of international cell innovation. Finally, congratulations once again on the successful establishment of CytoNiche's "3D Cell Intelligent Manufacturing and Regenerative Medicine Center - 3D FloTrix® Cell CDMO Platform".

Speech from Mr. Xu Jian, Director of Beijing Municipal Science and Technology Commission, and Zhongguancun High-tech Industry Promotion Center:

Since its establishment, CytoNiche has achieved the commercial transformation from technology to products in less than four years, making a number of major breakthroughs in the biotechnology industry. The establishment of CytoNiche's CDMO platform has accelerated the company's growth and laid a solid foundation for the industry development. Beijing Municipal Science and Technology Commission, Administrative Commission of Zhongguancun Science Park will continue to support and serve such original projects with gaming-changing innovation values as the 3D FloTrix® cell technology platform. The platforms in the system will jointly support the scientific research technology of high-tech institutions and enterprises to serve more businesses and provide beneficial services to support their market expansion efforts. We look forward to CytoNiche's technological breakthroughs in the CDMO field of gene and cell therapy and becoming a pioneer in the industry.

Speech from Professor Zhao Yi, Chief of Scientific Research and Director of Dermatology Department at Beijing Tsinghua Changgung Hospital:

It's a great pleasure to join the opening ceremony of CytoNiche's "3D Cell Intelligent Manufacturing and Regenerative Medicine Center - 3D FloTrix® Cell CDMO Platform". CytoNiche provides standardized cell preparations to cater clinical needs to achieve the large-scale intelligent manufacturing of cell culture, providing game-changing support to the field of intelligent cell manufacturing. We look forward to in-depth cooperation with CytoNiche to provide patients with better medical technology products and services.

Speech from Mr. Han Xing, Production Director of Sinovac Biotech Ltd.:

The products and technologies of CytoNiche has great potential in improving the large-scale production and quality of vaccines. In recent years, Sinovac has carried out in-depth cooperation with CytoNiche. I am deeply impressed by CytoNiche's efforts to excel in product quality for both microcarriers and cell bioreactors. The establishment of "3D Cell Intelligent Manufacturing and Regenerative Medicine Center" signifies CytoNiche's achievement of another leap in the course of its development. The initiation of the "Biological Manufacturing and Regenerative Medicine Forum" is also a great contribution from CytoNiche to promote the development of the biomedical industry. On behalf of Sinovac, I would like to extend our earnest congratulations and sincerely wish CytoNiche a brilliant future in the new journey.

Speech from Mr. Lian Yunfei, General Manager of Topcel Kangheng:

Independently developed by CytoNiche, the pharmaceutical excipient grade microcarriers that are registered in both China and the USA, and the relating core technologies play an important role in reducing cost and increasing efficiency in cell therapy products. The cooperation with CytoNiche has enabled Topcel Kangheng to use the 3D FloTrix® intelligent manufacturing system of CytoNiche for fully enclosed cell large-scale production (microcarrier + culture medium + bioreactor + cell harvesting device) to achieve the production and full quality inspection of 10 billion cells in a single batch in a short time, meeting existing quality standards while cutting production cost by 40%, labor cost by 75% (from 8 persons to 2 persons), and time cost by 50%. These data have been validated many times. We look forward to working with CytoNiche and the upstream, midstream and downstream enterprises in the cell industry to jointly create cell culture solutions dedicated to China.

Speech from Mr. Zheng Congyi, Chairman of Wuhan Canvest Biotechnology Co., Ltd.:

Thanks to CytoNiche for inviting us to join this opening ceremony. We look forward to the making of a new stage of development by CytoNiche for cell manufacturing industry with its original research technologies, forging ahead for a say in global 3D cell manufacturing.

Speech from Mr. Zhang Lin, General Manager of Science and Technology Service Co., Ltd. of BSTIG:

It is a great pleasure to join the kick-off meeting of "Biological Manufacturing and Regenerative Medicine Forum" and the opening ceremony of "3D Cell Intelligent Manufacturing and Regenerative Medicine Center". The opening of 3D Cell Intelligent Manufacturing and Regenerative Medicine Center - 3D FloTrix® Cell CDMO Platform signifies CytoNiche's beginning of a new chapter in the upstream process development of gene cell therapy, vaccine and protein production. In the future, we will work with CytoNiche and take the platform as the basis to provide professional and convenient services for the industrial chain development, scientific research resource integration and product transformation of innovation achievements in the biomedical field in Beijing.

【CytoNiche 3D Cell Intelligent Manufacturing and Regenerative Medicine Center - 3D FloTrix® Cell CDMO Platform】

At present, domestic enterprises offering CDMO services for gene and cell drugs are still trapped in using traditional two-dimensional culture method for cell preparation, making it difficult to meet the demands for fully enclosed automated GMP production and capacity expansion of cell therapy products. CytoNiche is actively engaged in this field by establishing the 3D FloTrix® cell technology platform that features enclosed, automated, and large-scale GMP-compliant preparation process and that covers an area of thousands of square meters.

Based on the exclusive biodegradable microcarrier technology and 3D cell preparation process of CytoNiche, a series of bottleneck problems in the industrialization development of cell therapy products has been solved, assisting a number of enterprises in establishing fully enclosed and automated cellular drug production lines to realize large-scale, automated, standardized and intelligent production and preparation of cellular drugs and their derivative products. CytoNiche provides CDMO services different from the existing CGT cell preparation processes, including technical research, process development and GMP production services that cover large-scale production and preparation of mesenchymal stem cells (MSC), exosomes and viruses from different tissue sources, to facilitate product transformation and clinical application of innovative achievements.

【Field trip of 3D cell intelligent manufacturing】

Dr. Liu Wei, General Manager of CytoNiche and Dr. Sun Yanxun, Director of CytoNiche Cell Transformation Center and head of 3D Cell Intelligent Manufacturing and Regenerative Medicine Center gave the guests a tour to the 3D cell intelligent manufacturing exhibition hall and 3D FloTrix® cell technology platform of CytoNiche. The research achievements, development overview and business layout of CytoNiche were explained in detail to the guests.

Visit to the 3D cell intelligent manufacturing exhibition hall of CytoNiche

Visit the 3D FloTrix® cell technology platform

【Kick-off meeting of Biological Manufacturing and Regenerative Medicine Forum】

After the tour, the kick-off meeting of "Biological Manufacturing and Regenerative Medicine Forum" was also held in the conference room of CytoNiche's new office area. Many industry experts, professors and entrepreneurs attended the meeting and discussed "How to integrate government, industry, universities, and medical institutions to work together on promoting cutting-edge innovation, transformation, and implementation in biological manufacturing and regenerative medicine".

Academician Chen Xiangmei proposed: There is still a long way to go for cellular drugs to advance from technical research to clinical mass production. We should strictly control quality safety and biological safety.

Mr. Xu Lize, Senior Manager of Technology Transfer from Huakong Technology Transfer Co., Ltd. of Tsinghua University, proposed: Research and development should be conducted in close connection with market requirements. The latest research and development technology and achievements should be transferred to enterprises to enable a positive loop between the research and development achievements and enterprise output.

Professor Liu Yongjun, Chairman of Beijing Baylx Biotech Co., Ltd., proposed: Large-scale cell culture is entering the era of automated culture 3.0. The cell therapy industry is also in need of a lot of talents to effectively tackle the difficulties and satisfy the demands of laboratories for the medicine manufacturing sector.

Dr. Fang Yu, founding partner of 3E Bioventures, proposed: Automated large-scale culture of 3D cells will be the trend of the future. We also need to persist in innovation and optimize product technology so as to serve more customers within the medicine industry.

Professor Liao Qinping, Head of the Department of Obstetrics and Pediatrics, Beijing Tsinghua Changgung Hospital, proposed: From the perspective of clinicians, though with low yield, exosomes have a wide range of applications in terms of gynecological diseases. We expect better solutions to improve exosome production capacity to benefit patients in the future.

Professor Zhang Lei, Director of the Department of Obstetrics and Pediatrics, Beijing Tsinghua Changgung Hospital, proposed: In the process of large-scale cell culture and preparation, quality control is a major challenge for cell industrialization. We believe that the original technologies of CytoNiche will promote the industrialization of cells.

Professor Li Qinggang, Deputy Director of Nephrology Department, Chinese PLA General Hospital, proposed: The safety of cells and their derivatives in clinical application should be emphasized and the focus in each key step of cell production and preparation.

In the end, the experts discussed new areas of application of modern engineering and manufacturing science in bioengineering and biomedicine, committing to promoting the industrialization of scientific research achievements and building an innovation hub in the biomedical industry.

【CytoNiche sets off a new era of industrialization of cell development】

Relying on its exclusive microcarrier technology and 3D cell preparation process, together with sound quality system and rich application experience, CytoNiche will strive to ensure quality and compliance to expand production scale and reduce development costs, achieving the large-scale commercial production of cell therapy products and accelerate the clinical transformation of drugs. With the vision of setting off a new era of industrialization of cell development, we will forge ahead with our industry partners to promote industry development and serve for human life and health.
 

[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, F20210000496). 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.