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