Successfully filed for 2 qualifications for pharmaceutical excipients from CDE

The 3D microcarriers independently developed by CytoNiche—"Gelatin Microcarrier" and "Gelatin Microcarrier Tablet for Cells", were evaluated to successfully qualify for pharmaceutical excipient by the Center for Drug Evaluation of the National Medical Products Administration on December 7, 2020 and February 24, 2021, respectively (registration number: F20200000496, F20210000003) and were approved. The product is the first domestic pharmaceutical microcarrier that is applicable for the cell drug development.

Completed the filing of 1 DMF qualification for pharmaceutical excipients from US FDA

(https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs), "Gelatin Microcarrier Tablet for Cells", the first domestic product for the production and preparation of cell therapy and regeneration therapy, completed the filing of the DMF qualification for pharmaceutical excipients (DMF: 35481). It is also the only microcarrier product in the DMF filing list announced on the official website of the US FDA.

Certified by the ISO9001 quality management system and ISO13495 medical device quality management system

CytoNiche adheres to the concept of providing customers with high-quality products and attaches great importance to product quality. The design and construction of the manufacturing platform comply with the relevant regulations of the GMP and ISO.The quality management system follows the GMP and ISO standards, and thus avoiding the contamination, errors, and confusion in the process to the greatest extent, and ensuring the safety and effectiveness of products.

Safety Evaluation by the National Institutes for Food and Drug Control and Jiangsu Center for Safety Evaluation of Drugs

For the microcarrier materials and lysis buffer of CytoNiche, a series of safety evaluation experiments have been completed by the third-party institutions (National Institutes for Food and Drug Control, Jiangsu Center for Safety Evaluation of Drugs), and summary reports have been formulated.On this basis, CytoNiche has worked with the National Institutes for Food and Drug Control to establish the testing methods and standards for detecting the specific amino acids in raw microcarrier materials and the residues with enzyme activities in the lysis buffer.