IntroductionCell Banks We ProvideCell Banking ProcessKey AdvantagesRelated Services
Introduction
Cell bank construction ensures a stable and intact by-cell population and sufficient material input for the cell line development of monoclonal antibodies or recombinant proteins. This need for construction is common to all industries aiming at pharma production, research, clinical diagnosis and application, including but not limited to biologics like vaccines and therapeutic proteins.
Creative Biolabs has employed the gold standard double-layer cell bank system, through which our cell banking service can provide the verified cell bank that meets the needs of our customers so that they can get supply of phenotypically consistent cells. With our combination of cell banking and services for antibody & protein, and vaccine manufacturing, we provide the cell line system from a master cell bank (MCB) to the production of a working cell bank (WCB) for routine laboratory use, which is crucial to manufacturing therapeutic production cells and used in later-stage therapeutic development.
We Offer the Following Cell Banks
Master cell bank development
A master cell bank (MCB) is critical to therapeutic product development and supports not only clinical development and manufacturing but also the commercial supply phase for biologicals. Many things can go wrong with MCB development. The use of improper and uncharacterized cell lines, genetic variation, and cell line contamination are just a few possible problem sources. Before regulatory submission, these cell banks must be well characterized and tested for contaminants such as bacteria, fungi, and mycoplasmas. Creative Biolabs offers full services to address all of these issues, and ensure that the MCB is stored under tightly controlled conditions to prevent contamination or degradation once prepared.
Working cell bank development
The working cell bank (WCB) is prepared from MCB under defined cell culture conditions. We offer a variety of working cell bank options, including mammalian cells, insect cells, and animal origin free (AOF) cell banking suites. We also produce and maintain working cell banks to support cell-based assays or as substrates for other assays. In addition, we also offer comprehensive biosafety testing services, including cell bank characterization and genetic stability assessments of the final producer cell lines.
Cell Banking Process
01 Selection and Authentication of Cell Lines
Choosing the right cell line is fundamental to a successful cell banking process. Creative Biolabs selects cells based on their stability, growth characteristics, and suitability for intended applications. The authentication process includes comprehensive genetic profiling to confirm species identity and detect any cross-contamination, ensuring the reliability of the cell bank. This careful selection process guarantees that every batch meets the highest standards for sensitive research or large-scale production.
Once the cells are selected, we create the perfect conditions to support their healthy expansion. This involves balancing key factors like nutrients, growth stimulants, temperature, and CO₂ levels to keep the cells thriving. For large-scale operations, our bioreactor systems come into play, ensuring we can cultivate high volumes of cells without compromising quality. Our advanced technology allows us to fine-tune conditions during cultivation, guaranteeing consistent, top-tier cell banks every time.
03 Cryopreservation Process
To ensure the cell bank cells are viable for longer storage period, cryopreservation is an important step. Dimethyl Sulfoxide (DMSO) is often used as a cryoprotectant to prevent ice crystal formation, which will cause damage to cell membranes and internal structures to a great extent if nucleation occurs. Creative Biolabs' experts achieve a relatively slow freezing speed to minimize cell stress during the cryopreservation, and always try their best to maintain the integrity of the cells and a high percentage of viability of the cells when the cells are thawed from the frozen state and ready to be used in research or production.
04 Storage in Ultra-Low Temperature Conditions
After freezing, cells are stored in liquid nitrogen at -196°C, a temperature at which all biological activity comes to a halt and degradation is prevented. A storage system at Creative Biolabs with closed cabinets and continuous monitoring and automatic alarm keeps the cell quality controlled and cells are still available for the practitioners.
For instance, we perform numerous viability assays and genetic stability tests. We also do comprehensive testing for contaminations, including Mycoplasma and other microbes. Sterility testing is also important for therapeutic-grade cell banks, as is endotoxin testing, again for biological applications. Our quality-control protocols ensure that our cell banks meet or surpass the highest standards in the industry.
06 Regulatory Compliance and Documentation
Operating within strict regulatory frameworks is essential in cell banking, especially for pharmaceutical and clinical uses. We document every batch in detail and provide Certificates of Analysis (COA) to verify the quality and traceability of our cell banks. Creative Biolabs follows all applicable guidelines, ensuring that our cell banks are ready for use in clinical trials, drug production, and other regulated activities with full compliance.
Key Advantages
Maintenance of a single master cell line.
Working cell banks with low passage numbers.
Identity confirmation by DNA Fingerprinting.
Purity testing including Mycoplasma, virus, and fungi detection.
With years of experience, Creative Biolabs' cell bank ensures that your biological production process complies with international guidelines. For more details, please feel free to contact us for project quotations and more detailed information.
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