Safety evaluation platform for cell therapy products
Service items
The quotation can be used for safety evaluation of cell therapy products. Currently, preclinical safety evaluations have been conducted on the pharmacological and pharmacokinetic studies of NKT cells, MSC cells, and CAR-T cells.
■ Cell count
■ Pharmacodynamic study
■ Single dose toxicity test
■ Repeated dose toxicity test
■ Safety pharmacology test
■ Pharmacokinetic test (including methodological establishment and validation)
■ Local toxicity test
■ Immunogenicity test (including methodological establishment and validation)
■ Tumorigenicity test
■ Tumor forming test
■ Soft agar cloning test
■ Cell count
■ Pharmacodynamic study
■ Single dose toxicity test
■ Repeated dose toxicity test
■ Safety pharmacology test
■ Pharmacokinetic test (including methodological establishment and validation)
■ Local toxicity test
■ Immunogenicity test (including methodological establishment and validation)
■ Tumorigenicity test
■ Tumor forming test
■ Soft agar cloning test
Company performance - obtaining clinical approval(Only some Company performance are displayed)
| Drug name | Acceptance No | Indication | Class |
| GKL-006 injection solution | CXSL2300567 | Used to treat irregular primary liver cell carcinoma | 1 |
