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GMP Bacteria Banking

The establishment of regulatory-compliant, robust, and traceable bacteria banks is critical for GMP plasmid production. PackGene provides reliable and economic bacteria banking  service that usually be submitted for testing by clients. The bacteria bank may determine which types of quality control and quality assurance assays must be performed for final plasmid release.

PackGene has the experience to quality you need for GMP banking, including the creation of master and working banks. We offer flexible bacteria banking options and methods for specific needs.

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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 on the Pharmacopoeia, the establishment of a bacterial bank should follow the following criteria for testing and validating, including and not limited to:

  • Identification of microorganisms
  • Physical and chemical properties
  • Growth characteristics
  • Purity
  • Sterile
  • 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 Biotech offers GMP bacterial library construction services for your project. Please send us your project requirements by submitting a request form or contact PackGene Technical Support for a value proposal.