Master Cell Bank Development

Master Cell Bank (MCB) development is a critical process in biological materials production. Since the quality of your final product is dependent on the quality of the cells used for its production, great care should be taken while developing master cell banks.

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. The master cell bank development services we offer address all these issues.

Custom Master Cell Bank (MCB) Development Service Description:

Pre-development

  • Cell line viability testing
  • Contamination testing
    • Mycoplasma
    • Sterility
  • Cell id (authenticity) testing
  • STR, CO1, surface expression marker testing
    • MCB specification development (concentration – total cells/vial, volume per vial, growth medium, freezing medium, serum, antibiotic, QC specifications)

Development

  • Modifications to cell lines (if required)
  • Cell line expansion
    • Selection of ideal growth medium and components
    • Culturing and sub-culturing
  • Thawing
    • 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 testing
  • Storage (liquid nitrogen vapor phase)
  • Documentation of stored materials (Accession records, cell banking records, quality control records, media batch preparation records, sterilization records).