GMP

Cell Banking Services

The concept of a two-tiered cell or virus bank, in which the Master Cell Bank (MCB; or MVB) which is used to generate Working Cell Banks (WCBs or MVBs), is generally accepted as the most practical approach to providing a supply of cell substrate or viruses for continued manufacture of a cell-based product.  

In some microbial expression systems, a new transformation is performed for each new cell substrate container lot, based upon using aliquots of thoroughly tested host cell banks and plasmid banks for each new transformation and on testing of each transformed cell substrate bank.  This transformed cell substrate bank is considered the MCB, and it is used as the source of cell substrate for production. Regulatory agencies consider this alternative system adequate because the transformation of bacteria and yeast is generally a very reproducible and easily performed process, unlike the events needed for transfection of metazoan cells.

BioMARC offers cell/virus banking services as part of a larger GMP project or contracted as separate services including evaluating the anticipated utilization rate of the cell/virus bank(s) for production, the expected intervals between generation of new cell/virus bank(s), and the criteria for qualification of cell/virus bank(s).

  • Facilities
  • Documentation
  • Quality Oversight
  • Reporting

Contact Information

Dennis Pierro, PhD                                                     
Director                                                                             
dennis.pierro@colostate.edu
(970) 491-8954

Sandy Brown
Contract Supervisor
sandra.brown@colostate.edu
(970) 492-4385
        
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