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The first local operational document implementing Order No. 818 has been released! The "Guangdong Province Biomedical New Technology (Stem/Somatic Cell Field) Clinical Research Registration Work Guide

2026/02/14



  Cell therapy product safety evaluation platform  
Shandong Xinbo is capable of conducting safety evaluations for cell therapy products. Currently, we have conducted pharmacodynamic studies, pharmacokinetic studies, and a full set of preclinical safety evaluations for CGT products such as NK, MSC, and CAR-T.
 ■ Cell counting
 ■ Pharmacodynamic study
 ■ Single-dose toxicity test (rodents)
 ■ Repeated-dose toxicity test (rodents)
 ■ Safety pharmacology test
 ■ Pharmacokinetic test (including method establishment and validation)
 ■ Local toxicity test
 ■ Immunogenicity test (including methodological establishment and validation)
 ■ Tumorigenicity test
 ■ Soft agar cloning assay


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