Cell Banking

Biomedical research is an intricate field that heavily relies on cell-based studies to unravel the mysteries of various diseases and develop innovative therapeutic solutions. The cell bank is the source of the entire biopharmaceutical, from the original cell bank to the main cell bank and the working cell bank, throughout the entire biopharmaceutical life cycle. A homogeneous, stable, and safe cell bank ensures the sustainability of production as well as the consistency of products.

Creative Bioarray, a pioneering company in life sciences research, has been at the forefront of providing comprehensive cell banking services to scientists worldwide. Our team of expert scientists is well-versed in the latest industry trends, ensuring that our processes remain at the forefront of scientific advancement.

cGMP Cell Banking

• In the highly regulated and competitive biomedical field, it is crucial to adhere to current Good Manufacturing Practices (cGMP) when establishing cell banks.
• Creative Bioarray helps our clients establish a cell bank that provides cells that are qualified, quality, and stable for the production of biological products. A fully characterized, homogeneous, cGMP-compliant master cell bank (MCB) and working cell bank (WCB) critically impact the safety, speed, and success of the journey from drug development to commercial biologics manufacturing.
• We understand the importance of cGMP compliance and consistently meet these requirements in our cell banking processes. We guarantee the reliability, quality, and traceability of cell lines by following cGMP regulations, including mammalian cell banking, stem cell banking, avian cell banking, and insect cell banking.

Fig.1 Generic cell banking process. (Pollock K and Sinden J, 2008)

GMP Cell Bank Characterization

• Characterization of cell banks is an essential step to maintain the integrity and identity of cell lines. 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. We conduct characterization on mammalian cell banks, stem cell banks, avian cell banks, and insect cell banks.

Process Development

• Cultured cells are used for the manufacturing of biologics such as vaccines, therapeutic proteins and antibodies, and cell therapy products.
• Creative Bioarray provides tailored solutions and enables your high-potential molecules to become a market success. Our integrated services from cell banking to process development of cell therapy products support our clients' challenges.
• We offer a full range of services related to cell banking, including but not limited to vaccines, recombinant proteins, protein conjugates, Fc-fusion proteins, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and therapeutic oligonucleotides.

Creative Bioarray strictly adheres to cGMP guidelines and implements rigorous quality assurance protocols throughout the cell banking process. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.