Custom services
Quality testing
We provide testing to evaluate the quality of your cell products for use in regenerative medicine. Our quality-testing services are compliant with international regulations like FDA, ICH, CFR, and USP and with Japanese Pharmacopoeia (JP). These services can be included as a part of product evaluation, process tests, and stability tests necessary for product release.
Safety testing of cells and raw materials
We offer quality control testing for cell and tissue products (and their raw materials) at various levels of stringency from GMP-compliant to simple, quick, and cost-effective tests for non-GMP grade materials.
| Typical safety tests | |
|---|---|
| For GMP-grade materials | |
| Sterility | • Direct inoculation method (JP) • Membrane filtration method (JP) • Rapid microbial detection method (JP) |
| Endotoxin | Kinetic turbidimetric method (JP) |
| Mycoplasma | Culture method, DNA staining method, real-time PCR (JP) |
| Human viruses | High-sensitivity detection by real-time PCR (target viruses: HIV-1, HIV-2, HBV, HCV, HTLV1&2, ParvoB19, EBV, CMV, WNV) |
| Chromosomal analysis | G-band analysis, Q-band analysis (by FISH or multicolor FISH)*. *non-GMP |
Q-band karyotyping of a mouse ES cell (40, XY)
G-band karyotyping of a human iPS cell (46, XY)
Purity testing
We know that the purity of your final product is critical. We provide both residual purity testing and cell purity testing to ensure that your cellular product is free of contaminating cell types and impurities from the manufacturing process.
| Purity tests for cellular products | |
|---|---|
| Residual purity tests |
We check for residual impurities that may remain in the final product from the manufacturing process, such as bovine serum albumin, cytokines, and viral vectors. |
| Cell purity validation | We use immunostaining with cell surface markers to detect cells with unintended characteristics. |
Cellular analysis
We offer various cellular analysis tests to evaluate the quality of your cell products for use in regenerative medicine. We leverage our extensive analysis techniques such as cell immunophenotyping, cytokine production assays, cytotoxicity and proliferative responsiveness assays, and next-generation sequencing.
| Cellular analysis tests | |
|---|---|
| Immunophenotype analysis | We use flow cytometry to characterize the cell surface antigen or endogenous antigen of target cells, such as T cell, B cell, NK cell, and regulatory T cell (Treg), to identify specific cell types in a heterogeneous population. |
| Protein measurement | ELISA is used to measure cytokines and growth factors in serum and cell culture supernatant. |
| Cell proliferation | Lymphocyte and general cell proliferation assays are performed using MTT and WST1. |
| Repertoire analysis | NGS assays are used to measure the diversity of the TCR and BCR repertoires. |
| Gene copy number | Target gene copy number is measured using real-time PCR to detect proviruses. |
| Genome mutations | We use the latest genome analysis techniques to evaluate chromosome structure and copy number and to identify mutations. |
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Takara Bio USA, Inc.
United States/Canada: +1.800.662.2566 • Asia Pacific: +1.650.919.7300 • Europe: +33.(0)1.3904.6880 • Japan: +81.(0)77.565.6999
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