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

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 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.