Cell bank engineering services ensure that strains used in biotechnological applications are stable, reliable, and of high quality. This discipline involves maintaining genetic stability, preventing contamination, and ensuring compliance with regulatory standards, all of which are critical for efficient and safe production of cell banks used for Biomanufacturing and production of Biopharmaceuticals in Industrial and Research settings.
Key concepts covered in our cell bank engineering services:
Master Cell Bank (MCB): The starting point, typically derived from a single well-characterized strain. The MCB serves as the primary, authentic reference source from which further cell banks are derived.
Working Cell Bank (WCB): This is a secondary collection of cell banks that are derived from the MCB. It is used for daily operations and fermentation processes to prevent contamination or genetic drift from the original MCB.
Storage: Cell banks are often stored under very low temperatures (liquid nitrogen, -80°C) to preserve their viability and genetic stability over time.
Strain monitoring & characterization: Regular testing, including sequencing and phenotypic assays, is used to ensure that the strains in the cell banks retain the necessary genetic traits and metabolic capabilities.
Cryopreservation is essential for storing cell banks over long periods without loss of viability. It involves freezing cells in a special cryoprotectant medium (e.g., glycerol or DMSO) and storing them at ultra-low temperatures.
Quality Control (QC): Periodic checks on the purity of cell banks are essential to prevent contamination (e.g., by unwanted microorganisms or by strain drift).
Sterility Testing: Ensuring the sterility of cell banks is critical to prevent the growth of unwanted microbes that could affect product quality or safety.
Fermentation Processes: Cell banks are used to supply consistent starter cultures for fermentation, ensuring that each batch of product is derived from genetically identical cells.
Pharmaceutical Production: Many biopharmaceuticals are produced using genetically modified cell banks. Cell banks play a role in ensuring that the production process is reproducible and compliant with regulatory standards (e.g., FDA or EMA).
Industrial Biotechnology: Cell banks are central to the consistent production of bio-based chemicals, enzymes, and other bioproducts using microorganisms in bioreactors.
Regulatory bodies like the FDA and EMA require rigorous documentation and quality control of cell banks to ensure the safety, consistency, and efficacy of biotechnological products. This includes demonstrating the traceability of the strain from the master cell bank and ensuring compliance with good manufacturing practices (GMP).
Cell banks may include engineered strains, which have been optimized for specific biotechnological processes. This can involve:
Directed evolution: A method of rapidly evolving microorganisms in a lab setting to enhance desirable traits (e.g., yield, robustness).
Genetic modification: Insertion, deletion, or modification of genes to optimize microbial strains for specific production processes.
Synthetic Biology: The design of entirely new synthetic microbes or modification of existing ones to perform highly specialized tasks.
High-throughput Screening: Used for identifying and isolating strains with improved characteristics or desirable traits faster and more efficiently.