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Yocon Biology participated in the drafting new regulation for the cell industry

Yocon

2023-07-07

Company Events


 

On June 30, the China Medical Biotechnology Association issued a public announcement on the "Quality Management Specifications for Raw Materials for Cell Therapy Products Production" (hereinafter referred to as "Specifications"). The preparation of this specification was organized and implemented by the Bone Tissue Bank Branch and the Regenerative Medicine Branch of the China Medical Biotechnology Association, and Yocon Biology participated in the drafting as the main drafting company.

 

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The birth of the standard "Specification" not only fills the vacancy in my country's targeted standards related to cell therapy but also regulates the quality management of raw materials used in the production process of cell therapy products. This standard gives the quality requirements for the raw materials used in the production of cell therapy products, as well as the specific characteristics and quality of some specific components or types of raw materials used in the production, such as serum and serum substitutes, recombinant proteins, tissue extracted proteins, etc. Require. Applicable to the quality management of raw materials for the production of cell therapy products, it aims to help suppliers and users of raw materials for production to achieve/perform quality management in terms of identification, purity, storage and stability, biosafety, and performance.

 

As a leading supplier of serum-free cell culture product research and development in China, Youkang Bio is also the first Chinese serum-free cell culture medium company to be registered and accepted by the US FDA. He has devoted himself to the field of cell culture reagents for many years and contributed to the formulation of this industry standard. Youkang's participation in the drafting of this industry standard is the recognition of Youkang by the cell therapy industry. Youkang will also live up to expectations and forge ahead to help the development of the cell therapy industry.

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Yocon Biology has been committed to the research of serum-free culture systems for many years. The current two core product lines, mesenchymal stem cell serum-free medium and NK cell serum-free medium have helped many pharmaceutical companies with their excellent and stable product performance. Carry out IND declaration work.

 

Yocon Biology serum-free cell culture products mainly include mesenchymal stem cells, immune cells, tumor cells, engineered cells, and auxiliary reagents for cell therapy. Cultivate the brand and build a solid foundation for the field of cell therapy from the source.