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Master Cell Bank Manufacturing

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Trust ATCC to develop your Master Cell Bank under cGMP

Master Cell Bank (MCB) and Working Cell Bank (WCB) development are critical processes in biological materials production. The quality of your final product is dependent on the quality of the cells used for its manufacturing, so great care should be taken while developing your 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 address all these issues.

Let ATCC take the risk out of creating and storing your master cell banks. From the initiation of your project to the distribution of your biological materials, ATCC is approved under current Good Manufacturing Practices (cGMP)  to provide the cell banking and biorepository services you need to support each stage of your project and ensure the security and integrity of your master cell banks.

MCB Development Service Description:

Pre-development

  • Cell line viability testing
  • Contamination testing – Mycoplasma testing, sterility testing
  • Cell identification (authenticity) testing – STR, CO1, surface expression marker testing
  • MCB specification development (assay-ready cells in the concentration you need – total cells/vial, volume per vial, growth medium, freezing medium, serum, antibiotic, QC specifications)
  • Immortalization of cell lines prior to developing a MCB

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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Cell Authentication

Cell authentication is essential. Skipping the authentication step can lead to lost time, money, and publications owing to cross-contamination and misidentification. ATCC can quickly confirm the identity of almost any cell line by using analytical techniques such as sterility testing, CO1, STR profiling for human or mouse cells, and mycoplasma testing so you have confidence in your research materials.

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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 under cGMP to confirm that the MCB and the WCB are genetically identical and 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 a variety of options grounded in decades of industry knowledge, making us your preferred strategic partner. Our team works with you through all stages of your project, 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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