Guideline on safety evaluation of cell-based medicinal products for animal use

Hyun-Ok Ku, Hee Yi, Young-Il Park, Byung-suk Jeon, Hwan-Goo Kang, Yong-Sang Kim, Bong-Kyun Park
2019 Journal of Veterinary Science  
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),
more » ... lity 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. This guideline aims to contribute to the proper evaluation of cell-based medicinal products (CBMP) for animal use and to ensure their safety, by presenting standard procedures for the safe evaluation of cell-based medicinal products conducted for manufacturing applications and marketing authorization of new veterinary medicinal products. Details not prescribed in this guideline are to be tested under the approval of the Animal and Plant Quarantine Agency (APQA).
doi:10.4142/jvs.2019.20.e14 fatcat:dv3bxgkfbrcp7p7csz4syiqtfe