Microbial cell banking plays a crucial role in the production of various biotechnological products, including pharmaceuticals, enzymes, biofuels, and industrial chemicals. It ensures a consistent and reliable supply of high-quality microbial strains throughout the production process. Creative Biogene provides microbial cell banking services, including GMP production or non-cGMP production master cell banks (MCB), working cell banks (WCB), end-of-production (EOP) cell banks, and research cell banks. Services are available at research grade, or at GLP or GMP grades.
The MCB is the primary source of the microbial strain used in production. It is typically generated from a well-characterized and genetically stable strain. The MCB is extensively tested and documented to ensure its identity, purity, and stability. The strain is propagated, cryopreserved, and stored under controlled conditions for long-term preservation.
The WCB is derived from the MCB and serves as the immediate source of inoculum for production. A small number of vials from the MCB are thawed, propagated, and tested to confirm their viability and stability. The resulting culture is used to establish the WCB, which is further characterized and stored under appropriate conditions.
When a production batch is scheduled, an aliquot of the WCB is thawed and used to inoculate a production-scale culture. This step involves scaling up the culture volume and optimizing the growth conditions to achieve a high biomass yield while maintaining strain characteristics.
Microbial cell banking ensures consistency between production batches. By using the same MCB and WCB, the genetic and physiological characteristics of the microbial strain remain stable over time. This allows for predictable and reproducible production outcomes, minimizing variability and ensuring product quality.
Before using the WCB or production culture for large-scale fermentation, quality control testing is performed to assess various parameters such as cell viability, identity, purity, and absence of contaminants. These tests help confirm the quality and integrity of the microbial strain and ensure that it meets predefined specifications before proceeding with production.
The MCB and WCB require periodic expansion and renewal to maintain their viability and stability. This process involves thawing vials from the cell banks, propagating the cells under controlled conditions, and generating new aliquots for long-term storage. Regularly updating and validating the cell banks ensures the availability of healthy and well-characterized strains.
Creative Biogene provides a comprehensive package of microbial cell banking services to support research, process development, preclinical studies, and clinical trials. The microbial cell banking process follows strict documentation, traceability, and quality management systems to comply with regulatory requirements. Our service is entirely customizable and flexible thus can fit in no matter how you run projects.
If you are interested in our services, please contact us for more details.