GMP Bacteria Banking
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.
| 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.
