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Master Cell Bank Manufacturing

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Quality cells equal quality products

Master Cell Bank (MCB) and Working Cell Bank (WCB) development are critical processes in biological materials production. Since the quality of your final product is dependent on the quality of the cells used for its manufacturing, 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. Our processes, experience, and 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 identification (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).
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Molecular Analysis

If you can't find the nucleic acids you need, we can grow, extract, and purify nucleic acids from most ATCC cultures in larger quantities. Rely on ATCC for molecular analysis, viral quantitation, and next-generation sequencing.

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Working Cell Bank Manufacturing

Working cell banks (WCBs) are prepared from master cell banks (MCBs) under defined cell culture conditions. Quality control tests, via DNA profiling techniques, are performed to confirm that the MCB and the WCB are genetically identical, as well as to ensure the WCB is free of contaminants.

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Master Cell Bank Services

Contact us using the form below for more information on our services, or to let us know that you are ready to start your project.

Our laboratories are able to provide you with customized options grounded in decades of industry knowledge, making us your preferred strategic partner. Our team works with you through all stages of your custom project process, from the initial inquiry, design and initiation of your project, to the production, characterization, packaging, storage and distribution of your biological materials. This allows you to focus on your core competencies while we focus on what we do best, producing, managing and delivering the highest quality biological materials, globally.




















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