What are the requirements for a large-scale clinical-grade “cell factory”? Are your cells in a safe “big factory” or a “small workshop”?

Cell storage as a popular new global trend, is related to human life and health management. Where to exist this precious biological resource of their own is especially critical!

In the previous article, we analyzed the primary conditions for choosing a cell storage organization, (why cell storage has become the immediate need of every family in the new era? How to choose a reliable storage organization?) In addition, the purpose of cell storage is to store value for health, to treat diseases in the future when needed, or even to save lives. Therefore, how can we ensure that the cells used for treatment in the future are living and at the same time effective cells? The requirements for cell preparation and storage technology, and even clinical research and development capabilities of cell storage organizations are even higher.

The point is, how to see whether the storage organization has sufficient technical capabilities?

Is there a “cell factory” that produces clinical-grade stem cells on a large scale?

Compared with other traditional medical treatments, stem cell products are more complex, it is a kind of living, living biological agents, therefore, its production and preparation need very harsh, rigorous, sound environmental conditions, quality management system and unified standards, in order to ensure the quality of each batch of products, to achieve stable therapeutic effects! Any small deviation in the cell preparation process will have a great impact on the quality of cell preparations, thus affecting the safety and effectiveness of clinical applications.

Source product biological construction of Hunan Province cell preparation center, and Hunan Province cell tissue bank for the core module of the South China source product stem cell science and technology park, cell preparation workshop by the third-party testing organizations, all of its performance indicators fully meet the standards of the clinical grade cell drug GMP, cell preparation and production of the core area has reached the level of B + A, the annual preparation of clinical-grade cells more than 100,000 copies of the cells prepared for drug development and clinical applications can be used directly. The cells prepared can be directly used for drug development and clinical application.

Has the quality of cells been certified by the industry authority?

The China Association of Pharmaceutical Biotechnology under the Ministry of Health of the People's Republic of China has issued the “Self-Regulatory Code of Quality Management of Stem Cell Preparation” to regulate the preparation of stem cell preparations and improve the quality management of stem cell preparation.

In May 2019, Source Bio obtained the ISO-9001 quality management system international certification during the trial production period.

On December 19, 2019, Yuanpin Bio successfully passed the acceptance of “Self-regulatory Standard for Quality Management of Stem Cell Preparation” by China Association of Pharmaceutical Biotechnology, and is the only enterprise in Hunan Province and the third enterprise in China to obtain the “Certificate of Qualified Quality Management of Stem Cell Preparation” issued by the industry association. It is the only enterprise in Hunan Province and the third enterprise in China to obtain the “Certificate of Quality Management of Stem Cell Preparation” issued by the industry association.

Meanwhile, our umbilical cord mesenchymal stem cells have passed the comprehensive review tests of biological properties, microbial safety, biological safety and biological effectiveness conducted by the Drug Safety Evaluation Center (GLP Laboratory) of Hunan Provincial Drug Administration, and have obtained the qualified test report.

Does it have strong R&D strength?

At present, in the field of clinical research in China, limited by policy restrictions, generally adopts the mode of cooperation between tertiary hospitals and stem cell storage institutions, and this kind of cooperation has achieved breakthrough results one after another, which also confirms the great potential of stem cells to the people.

Yuanpin Bio, in full cooperation with Xiangya System Hospital of Central South University and Nanhua System Hospital, has established “Joint Laboratory of Stem Cell and Regenerative Medicine Transformation” and “Cell Therapy Clinical Research and Application Base” to accelerate the research and application of stem cell clinical technology. In order to accelerate the research and application of stem cell clinical technology, the company has established an integrated research and development system of “industry, academia, research and medicine”.

The company has also set up a team of research experts led by Pei Gang, president of the Chinese Society of Cell Biology and academician of the Chinese Academy of Sciences, with Prof. Wang Jian, one of the founders of China's first stem cell bank, Prof. Xue Zhigang of the Stem Cell Research Center of Tongji University, and Prof. Wang Wenjun of the First Affiliated Hospital of Nanhua University as the core of the team. At present, the company has 19 core proprietary technologies and more than 20 patented technologies in stem cell and immune cell production and preparation, quality management and cell clinical research!

In conclusion, to store stem cells and immune cells for health backup, please recognize professional institutions with strong technical ability when choosing storage institutions!