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GMP Bacteria Banking

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PackGene is capable of establishing and maintaining regulatory-compliant, robust, and traceable bacteria banks that are critical for GMP plasmid production.

PackGene has the experience needed to establish and maintain high-quality GMP bacterial banks including both master and working banks. We offer flexible bacteria banking options with a variety of established production and quality control processes to meet your specific needs. Our expert team will work with you to design a customized project proposal that includes quality control and quality assurance assay requirements for final plasmid release that are based on your specific needs.

Interested in our AAV services? Please contact us for a free consultation or  submit a request for a quotation.
Banking Service Function & Purpose e.g
Bacteria Master/Main Bacteria Banking Fully characterized used to establish working bacteria banks DH5α,STbl3, etc
Working Bacteria Banking Used for expansion and production of final plasmid products
Bacteria Banks Validation

In accordance with the regulatory requirements in the Pharmacopoeia, establishing a GMP bacterial bank should adhere to the following testing criteria for validation:

  • Identification of microorganisms
  • Physical and chemical properties
  • Growth characteristics
  • Purity
  • Sterility
  • Mycoplasma
  • Bacteriophage
  • Genetic markers of the genome or plasmid
  • Restriction digestion
  • Plasmid or genome insert sequence
  • Activity
  • Antibiotic resistance
  • Gene copy number
  • Storage and passage stability of seed bank
  • Plasmid loss rate

PackGene offers GMP bacterial library construction services that adhere to all required testing criteria. To learn more, please send us your project requirements by submitting a request form or contact PackGene Technical Support for a project quote.