DASEA^® Regencarrier^® bionic microcarriers obtain testing report from NIFDC

On March 18th, the REGEN-αGEEK research team announced another achievement: its self-developed cell culture microcarrier, DASEA^® Regencarrier^® bionic microcarriers, has obtained a testing report from the authoritative National Institutes for Food and Drug Control (NIFDC) regarding the residual amount of microcarriers and lysate residues in cell preparations. This recognition follows previous qualifications including registration as a pharmaceutical excipient with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and dual Drug Master File (DMF) filings with both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA).

DASEA^® Regencarrier^® bionic microcarriers are gelatin-based microcarriers for cells (for injection) independently developed by REGEN-αGEEK. The key testing items in this report focused on the residual amount of microcarriers and lysate residues in cell preparations manufactured using DASEA^® Regencarrier^® bionic microcarriers. The test results confirmed compliance with relevant regulations. Since commencing research and development on bionic microcarriers and large-scale stem cell expansion in 2009, the REGEN-αGEEK research team has consistently prioritized product quality and safety. The DASEA^® Regencarrier^® bionic microcarriers have undergone comprehensive testing by third-party institutions for multiple indicators including sterility, endotoxin levels, material residues, and porosity. All relevant test results have met national or industry standards.

Endotoxin testing report from a third-party inspection agency