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Master Cell Bank Manufacturing
After generating a therapeutic cell line according to your requirements, we also offer cell bank manufacturing to create both a Master Cell Bank (MCB) and a Working Cell Bank (WCB). These cryopreserved cell banks help prevent genetic variation and contamination during subsequent manufacturing processes.
The MCB serves as the main long-term source of the cell line, while the WCB is prepared from the MCB for routine use in production. Our process involves the following steps:
Master Cell Bank Pre-Development
- Cell bank characterization and authenticity testing, including cell surface marker analysis and next-generation sequencing of the transcriptome and/or genome
- Cell bank viability testing
- Cell bank mycoplasma testing and sterility testing
- Cell bank manufacturing specifications for manufacture-ready cells at the required concentration, including total cells per vial, volume per vial, growth medium, freezing medium, serum, antibiotics, and QC specifications
- Immortalisation of cell banks for long-term use and consistent manufacturing
- Cell bank characterization and authenticity testing, including cell surface marker analysis and next-generation sequencing of the transcriptome and/or genome
Master Cell Bank Development
- Modifications to cell lines (if applicable)
- Cell line scaling for cell bank manufacturing, including determination of the optimal growth medium and supplements, culturing, and sub-culturing
- Assessment and validation of preservation methods for cell bank manufacturing, including cryoprotection toxicity tests (temperature, concentration, duration, etc.) and cooling profile investigation
- Documentation of procedures, cultures, and reagents used for cell bank manufacturing
Master Cell Bank Post-Development
- Post-development QC for cell bank manufacturing
- Storage of cell banks and related materials
- Documentation of stored materials, including records of access, QC, cell banking, and sterilisation
Working Cell Bank Development
- Obtaining starting material or cells for working cell bank manufacturing, including commercial cell lines and patient cells
- Development of product specifications for working cell bank manufacturing, such as product description, total cell count concentration (total cells/mL), minimum volume/vial, and estimated passage at completion
- Working cell bank establishment through expansion
- QC testing for working cell bank manufacturing, including viability, pathogen testing, and related assessments
- Storage and shipment of the working cell bank
Other Service
- Cell isolation, scalable cell cultivation, manipulation
- Cell Storage
- IPS Cell line derivation & Differentiation
- Spheroid Derivation Services
Need help?
If the service you are looking for is not listed, or you require specialist modification to an existing process, please do get in touch, and our team will build a bespoke offering with you.