Guideline on safety evaluation of cell-based medicinal products for animal use
- Author:
Hyun Ok KU
1
;
Hee YI
;
Young Il PARK
;
Byung suk JEON
;
Hwan Goo KANG
;
Yong Sang KIM
;
Bong Kyun PARK
Author Information
- Publication Type:Review
- Keywords: Cell-based medicinal product; cell therapy; safety evaluation; animal use
- MeSH: Animals; Carcinogenicity Tests; Cell- and Tissue-Based Therapy; Classification; Karyotyping; Kinetics; Plants; Quality Control; Quarantine; Toxicity Tests
- From:Journal of Veterinary Science 2019;20(2):e14-
- CountryRepublic of Korea
- Language:English
- Abstract: With the increased use of cell therapy in the veterinary sector, there is a growing demand for the development of cell-based medicinal products and the determination of their safety. Currently, the Korean Animal and Plant Quarantine Agency has established a guideline for evaluating the safety of cell-based medicinal products for animal use. The guideline includes items related to definition, classification, management, manufacturing procedure and quality control (standard and test method), stability testing, toxicity testing, pharmacological testing, and performance of clinical trials. In addition, testing protocols related to safety assessment of animal cell-based products such as chromosome karyotyping, tumorigenicity testing, confirmatory testing of biodistribution and kinetics, and target animal safety testing are described in detail. Moreover, because cell-based medicinal products are novel therapies, deviations from traditional designs may be justified in order to obtain relevant safety information on the treatment. Additionally, this guideline can be amended on the basis of new scientific findings.
