On August 17, the Center for Drug Evaluation of the National Medical Products Administration issued a notice to solicit public opinions on the "Guideline for Pharmaceutical Research and Evaluation of Human-Derived Stem Cell Products (Draft for Solicitation of Opinions)".

The guideline aims provide industry standards and guide the pharmaceutical research of human-derived stem cell products. The guideline also emphasizes the preferential use of continuous and closed production practice, and clarifies that pharmaceutical-grade raw excipients should be preferentially used in the production process.

As an upstream process service provider for the large-scale preparation of human-derived stem cells, CytoNiche has always maintained a forward-looking and ever-updating ideas in product R&D and technological innovations. As the first pharmaceutical excipient that is applicable to the cell drug development, the flagship product microcarrier has obtained the qualification for pharmaceutical excipient from CDE (registration number: F20200000496; F20210000003) and FDA/DMF qualification (DMF: 35481).

The 3D FloTrix® series and complimentary practice developed based on 3D microcarriers can realize the large-scale preparation and production of human-derived stem cells, enable enclosed and automated production practice, and thus realize the collection of high-quality cells and cell products.CytoNiche will continue to closely follow industry policies and provide industry clients with an overall solution for large-scale cell preparation.