Master cell bank manufacturing

After generating a therapeutic cell line according to your requirements, we also offer the development of MCB and WCB that will be cryopreserved to prevent genetic variation and contamination during the subsequent manufacturing processes. Our process involves the following steps

Pre-development

Cell identification (authenticity) testing – cell surface expression marker testing, next-generation sequencing of transcriptome and/or the genome
Cell line viability
Mycoplasma testing, sterility testing
Establishing specifications: manufacture-ready cells in a required concentration – total cells/vial, volume per vial, growth medium, freezing medium, serum, antibiotic, QC specifications)
Immortalisation

Development

Modifications to cell lines (if applicable)
Cell line scaling (determination of optimal growth medium and supplements, culturing and sub-culturing)
Assessment and validation of preservation methods, cryoprotection toxicity tests (Temperature, concentration, duration, etc.), cooling profile investigation
Documentation of procedures, cultures, and reagents used

Post-development

Post-development QC
Storage
Documentation of stored materials (records of accessing, QC, cell banking, sterilisation).

Working Cell Bank Development:

Obtaining starting material or cells (commercial cell lines, patient cells)
Development of product specifications (eg, product description, total cell count concentration – total cell/mL, minimum volume/vial, estimated passage at completion)
Working cell bank establishment (expansion)
QC testing (viability, pathogens, etc.)
Storage and shipment

Other Service

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.