cGMP CHO Cell Banking

As the name suggests, Chinese hamster ovary cells, or in short CHO cells are derived from the ovary of a small rodent called the Chinese hamster. Due to their similarity to the human cell system, CHO cells are used in biological and medical research, primarily such as genomic and chromosome studies, toxicity assays, and nutrition and gene expression. CHO cells are by far the most commonly used production cell lines in the pharmaceutical industry with a safety profile established over 20 years.

Creative Bioarray provides a cGMP-compliant CHO cell bank by following the industry-standard cell bank system to help our customers worldwide. Our platform is equipped with cGMP production facilities, and extensive technical and regulatory expertise to support our clients' research. We also have a wealth of experience and knowledge and will advise on the most appropriate and cost-effective testing strategy to meet scientific and regulatory requirements.

Our Cell Services Cover the Complete Lifecycle of a Cell Bank

• Testing of developed cell lines, including CHO-K1, DXB11, S, DG44 prior to bank construction.
• Cell banking for master cell banks (MCB) under cGMP conditions. In the industrial process, we use serum-free media strictly according to recent regulations.
• After the establishment of an MCB, a working cell bank (WCB) is constructed from the MCB.
• Complete validation and release of MCB and WCB in compliance with national regulatory requirements.
• Long-term storage of cell banks under cGMP management.

Fig.1 Origin, names, and constructed history of industrially relevant CHO cell lines. (Wurm F and Maria W, 2017)

Our CHO Cell Bank Manufacturing Features

• Performing a verified suitable environment, including MCB and WCB. cGMP operations are conducted in ISO 7 classified locations and the suites can be operated in positive pressure.
• Dedicated facility for CHO cell banks using serum-free and animal component-free media.
• Manufacturing in a closed system. Closed manufacturing system achieved by using sterile single-use solutions, including options for shake flask manufacturing, cell culture fermentation, aseptic transfers, and culminating in automated vial filling.
• Quality assurance. We offer this as a fully broth-qualified manufacturing platform for added process safety and sterility assurance.
• Extensive environmental monitoring program supporting manufacturing platform.

Example: Manufacturing a CHO Cell Bank

• Pilot manufacturing (non-GMP). Following the acceptance test, we expand the cells at a small scale and then at full scale to confirm the manufacturing process. We confirm the cell proliferation profile.
• Manufacturing under cGMP conditions. We manufacture the cell bank in our cGMP facility and then deliver manufacturing plans, documents, and reports, and 100-300 vials of cell bank with 3 x 10⁶ cells/vial.
• Quality testing, such as basic microbiology assay, identity testing, genetic stability assay, purity testing, tumorigenicity testing, and oncogenicity testing.

Creative Bioarray provides cost-effective, high-quality, and hassle-free services to our customers worldwide. ​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.