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 cell 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 standards that dictate final plasmid release requirements based on your specific needs.
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
- Purity
- Activity
- Plasmid or genome insert sequence
- Physical and chemical properties
- Sterility
- Antibiotic resistance
- Storage and passage stability of seed bank
- Growth characteristics
- Mycoplasma
- Gene copy number
- Genetic markers of the genome or plasmid
- Restriction digestion
- Bacteriophage
- 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.
Resources
Are pH measurements required, and is a large amount of sample wasted to carry out pH measurements?
Measurement of pH is a mandatory for the release of rAAV Fast Service deliverables. A micro pH electrode may be used to save sample and thus the required sample volume to perform pH measurements is only ~15uL-100uL.
What is loading?
In accordance with the Pharmacopoeia General Rules 0942, we use the minimum filling quantity inspection method for detecting sample loading quantity.
How to interpret A260/A280 value?
A260/A280 is the ratio of sample absorbance measured at wavelengths of 260nm and 280nm. This measure is commonly thought to represent the ratio of DNA to protein in a sample. For rAAV, A260/A280 can used as a measure of the full to empty shell rate and to identify protein contamination. Low A260/A280 levels may suggest that the empty shell rate is high. Alternatively, high A260/A280 may suggest that the sample has been contaminated with proteins that are not incorporated into the AAV capsid shell. The greatest advantages of this measure are its convenience and speed.
What tests are performed to differentiate rAAV capsid proteins from specific protein impurities?
SDS-PAGE is used to identify rAAV capsid proteins. In addition, SDS-PAGE can be used to directly identify specific protein impurities including the presence of host proteins, BSA, or degraded AAV capsid proteins.
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