Axcelead supports research into regenerative medical products, drawing upon the technology and expertise cultivated in the field of drug discovery research
Axcelead supports the evaluation of differentiated/undifferentiated cells and the exploration of promoting factors of differentiation, an early and important step in the research and development of products including human cell-derived pharmaceuticals. Furthermore, various analytical tools, for example histopathological analysis, are used in conjunction with live animal experiments to better evaluate the efficiency and safety of target cells, while always keeping clinical practice in mind.
Step 1- Cell Quality Evaluation
Our in-house analytical technology makes it possible, through cell evaluation, to explore both differentiation-inducing conditions and differentiation-promoting factors.
It is also possible for us to search for compounds that improve differentiation efficiency through the use of a large scale compound library.
— Axcelead Services —
- 1. Single-Cell RNA-seq Analysis Utilized to Evaluate Products such as Those Used in Cellular Medicine
- 2. Analysis of Differentiation Status using Cell Culture Metabolomics and Proteomics
- 3. Phenotypic screening using iPS cells
Go to In vivo test using differentiated target cells
Step 2- In Vivo Assay
By conducting long-term efficiency studies* using transplanted cells differentiated and induced from human iPS cells, the subjects being animals with high clinical extrapolation, it is possible to predict the number of cells to be transplanted into humans and the efficacy of cell transplantation for use in clinical trials.
*All animal studies are conducted at AAALAC-approved facilities.
- 4. Generation of Genetically Modified Mice and Rats through Use of Genome Editing Technology
- 5. Additional Genome Editing to Severely Immunodeficient Mice
- 6. Immunosuppressed large animal models for Long-term Efficacy & Safety Testing
Moving to the acquisition of bridging data for clinical use
Step 3- Supporting Clinical Practice through Non-Clinical Data Acquisition & Analysis Services
Axcelead evaluates the cell engraftment and biocompatibility after transplantation using multiple approaches.
Depending on client needs, we can obtain clinical bridging data by customizing the analytical methodology and study design.
- 7. Efficacy & Safety Evaluation through the Use of Molecular Pathology and Histopathological Analysis
- 8. Efficacy & Safety Evaluation using Biomarker analysis
Click the Following Links for Further Details of Each Step
- Step 1- Go to Cell quality evaluation
- Step 2- Go to In vivo assay
- Step 3- Go to Supporting Clinical Practice through Non-Clinical Data Acquisition & Analysis Services