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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||For non-GMP-grade materials|
|Sterility||• Direct inoculation method (JP)
• Membrane filtration method (JP)
• Rapid microbial detection method (JP)
|Endotoxin||Kinetic turbidimetric method (JP)||Real-time PCR|
|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)||Real-time PCR
(for 6 or 9 kinds of human viruses)
|Chromosomal analysis||Please contact us for more information.||G-band analysis, Q-band analysis
(by FISH or multicolor FISH)
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.|
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.|
|Cytokine analysis||We use flow cytometry to determine which cytokines are produced in the target cells in response to peptide stimulation.|
|Multiplex analysis||We perform Bio-Plex analysis of various cytokines, chemokines, and growth factors in serum or culture supernatant, including measurement of cytokines such as interleukin, interferon, and tumor necrosis factor, and serial analysis of cytokine production for comparison between samples.|
|Protein measurement||ELISA is used to measure cytokines and growth factors in serum and cell culture supernatant.|
|Cytotoxicity analysis||We measure NK activity in peripheral blood cells and cultured cells, as well as cytotoxicity in response to tumor peptide antigens and tumor antigen cell lines.|
|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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