Toward Public Health & Safe Society
Internal Distribution Test
The final biodistribution aspect after injection or transplant of advanced biomedicine such as cell therapy, gene therapy product, DNA/RNA vaccine, nucleic acid treatment can affect not only the effectiveness but also the unintended safety, so the in vivo movement, distribution and persistency is very important in securing the safety of treatment, thus requiring the assessment on this.
For the biodistribution assessment test of advanced biomedicine, the test use rodent, non-human primate and animal models for human diseases to conduct analysis various molecular biological analysis such as real-time PCR, digital PCR or imaging, and decides the in vivo movement, distribution and persistency of test substance or transgene.
Field of Test
Analytical Method Validation
- Conduct validation in accordance with (K)FDA guidance or ICH guideline before the biodistribution test on advanced biomedicine
Biodistribution Test Using Rodent
- Inject test substance to ICR, Nude and SCID mouse, SD rat and use real-time PCR device to check the biodistribution and the point of dissipation
Biodistribution Test Using Non-Human Primate
- Inject test substance to non-human primate and use real-time PCR device to check the biodistribution and the point of dissipation
Biodistribution Test Using Animal Models for Human Diseases
- Inject test substance to animal models for human diseases(rat, mouse) that are applicable for test substance and use real-time PCR device to check the biodistribution and the point of dissipation