Stem Cell Bank Characterization

Stem cells are tiny cells with great potential & can save lives. Stem cells are the master cells that act as basic building blocks of the human body. These cells have the unique ability to transform into specialized cells like blood cells, brain cells, muscle cells, bone cells, and so on. Since the development of stem cell banks, there has been tremendous excitement surrounding their potential to transform our understanding of cell and molecular biology and to develop treatments for a wide array of diseases with unmet medical needs.

Creative Bioarray provides comprehensive and detailed services for stem cell bank characterization to help our customers worldwide in the field of cell banks. We employ multiple assays to assess cell banks from different aspects, including but not limited to PCR, qPCR, next-generation sequencing, and transmission electron microscopy. Rapid and accurate results will be delivered to assist customers in accessing the quality of cell banks as soon as possible.

Master Cell Bank Characterization and Testing

• Microbiological characteristics, including but not limited to sterility, bacteriostatic/fungistatic activity, and mycoplasma (presence of agar cultivable and non-agar cultivable mycoplasma).

• Human pathogen testing by using PCR, including HIV (Human Immunodeficiency Virus 1 and 2), HTLV 1 and 2, CMV (Human Cytomegalovirus), EBV, HP-B19, HCV (Human C virus), HBV, HHV (Herpes virus 6, 7 and 8).
• Virus testing, such as in vitro assay for adventitious viral contaminants by culture on MRC-5, Vero, and Hs68 cells for 28 days; in vivo assay for adventitious viral contaminant by culture in adult and sulking mice, chicken eggs, and guinea pigs; murine adventitious agents including MAP (murine antibody testing) and murine retroviruses; ultrastructural evaluation of cell cultures for viral particles with transmission electron microscopy; reverse transcriptase assay with PCR, etc.
• Cell identity assays, such as characterization of cell morphology and growth with G-banding, the genetic fingerprint of the hESC line with G-banding, and cell line species identity by isoenzyme analysis with gel electrophoresis.

Working Cell Bank Characterization and Testing

• Routine testing, including but not limited to microbiological characteristics, sterility, and mycoplasma.
• Virus testing, such as in vitro assay for adventitious viral contaminants.
• Cell identity assays, such as characterization of cell morphology and growth, etc.

End-Of-Production Cell Bank Characterization and Testing

• Identity assay, including but not limited presence or absence of phenotype-specific markers, protein secretion, mRNA and microRNA expression, morphology, adherence, and differentiation potential.
• Purity assay, including the absence of cell contaminant markers, marker expression, cellular and non-cellular impurities profile assessment, and others.
• Potency assay, including expression or secretion of relevant biological substances, such as recombinant proteins, glycoproteins, lipoproteins, growth factors, enzymes, cytokines, etc.; formation of cellular and extracellular matrices; formation of cellular and extracellular structures; cell-to-cell interactions; migration; proliferation or differentiation.
• Stability assays, such as proliferation, recovery, stress markers, phenotypic stability, and others.
• Tumorigenic potential, such as the absence of residual PSCs within the product, stable growth kinetics, chromosomal stability, etc.

As a pioneer in biosafety testing service, Creative Bioarray provides cost-effective, high-quality, and hassle-free services to our customers worldwide. We offer international testing methodologies for stem cell bank characterization. We provide our clients with direct access to our experts and prompt responses to their questions. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.