GMP Cell Bank Characterization

Cell banks are created by controlled rate freezing of pooled cell suspensions. Each line is characterized by freedom from adventitious agents, identity, and biological behavior in immunosuppressed animals. According to current regulations (ICH guideline Q5A), we must consider the following aspects, including the origin and history of the cell line cellular morphology and growth characteristics, cellular identity, purity of the cell lines, tumorigenicity, and oncogenicity, genetic stability, etc. At Creative Bioarray, cell line characterization is performed for master cell banks (MCB), working cell banks (WCB), and end-of-production cells (EPC) or cells at the limit (CAL) of in vitro cell age used for production.

As an established leader in the field of cell science, Creative Bioarray's expertise in cell banking is unparalleled. Our QC testing plans meet requirements for cell bank release and are designed to meet regulations with assays validated to GMP standards. Ready-to-use testing schemes may be added to existing strategies or customized for the needs of specific programs.

Mammalian Cell Bank Characterization

• Mammalian cells are routinely used in the biopharmaceutical industry. Cell banking to ensure the preservation of these cells at low temperatures for an extended period is at the core of establishing a manufacturing process utilizing these cells and various strategies have evolved to ensure the recovery of viable and functional cells.
• Creative Bioarray now provides comprehensive services for mammalian cell bank characterization according to the biological properties of the cells, their cultivation history, and available testing procedures, including identification, genetic stability, purity, viability, tumorigenicity testing, etc.

Fig.1 Cell bank characterization.

Stem Cell Bank Characterization

• Stem cell banking is the process of procuring precious stem cells from the human body, processing and storing them for potential future use in stem cell treatments.
• Stem cell banks use low temperatures to preserve the biological properties of stem cells, and protect them from contamination and degeneration. Standardized and quality-controlled preservative procedures are required for any stem cell bank to preserve the cells for longer periods without losing their properties.
• We provide services for stem cell bank characterization, including microbiological characteristics, human pathogen testing, virus testing, cell identity, and others.

Avian Cell Bank Characterization

• The development of continuous avian cells that grow in serum-free medium in suspension culture offers several opportunities for the manufacture of vaccines using viral vectors or viruses that grow poorly or not at all in mammalian cells, and also for the manufacture of other biologicals such as therapeutic monoclonal antibodies.
• We provide services for avian cell bank characterization, including cell morphology, cell viability, cell growth curve, microorganisms, karyotype, isozymes, etc.

Insect Cell Bank Characterization

We offer characterization programs that include testing assays designed to detect microbial and viral contaminants, verify cell line identity, and confirm the genetic stability of cell banks.

Creative Bioarray is always devoted to providing high-quality and satisfactory service to our customers. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.