GMP Bacteria Banking
The establishment of regulatory-compliant, robust, and traceable bacteria banks is critical for GMP plasmid production. PackGene provide reliable and economic bacteria banking 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 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 | ||
Specifications tested for bacteria banks
According to the regulations of Pharmacopoeia, the bacteria banks are recommended to test the below specifications, including but 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
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