J Vet Sci.  2019 Mar;20(2):e14. 10.4142/jvs.2019.20.e14.

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

• Ku HO
• Yi H
• Park YI
• Jeon BS
• Kang HG
• Kim YS
• Park BK

• KMID: 2454016
• DOI: http://doi.org/10.4142/jvs.2019.20.e14

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.

Keyword

Cell-based medicinal product; cell therapy; safety evaluation; animal use

MeSH Terms

Animals*
Carcinogenicity Tests
Cell- and Tissue-Based Therapy
Classification
Karyotyping
Kinetics
Plants
Quality Control
Quarantine
Toxicity Tests