GMP Cell Banking


PackGene is well versed in the development and maintenance of 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.

Our Services
Banking Service Function & Purpose e.g
Bacteria Master Cell Banking Fully characterized used to establish working bacteria banks JM108, DH5α,STbl3, etc
Working Cell Banking Used for expansion and production of final plasmid products
Cell Bank Quality Control
Assay Method
Plasmid Yield Ultraviolet-visible spectrophotometry (A260)
Final Product Appearance Testing Plasmid Visual Testing
Host Cell Identity Bacterial Colony Morphology
Host Cell Identity Gram Stain Analysis
Physiological and Biochemical Detection IMViC test
Host Cell Purity LB Agar
Cell Bank Viability CFU/mL plate count analysis
Antibiotic Resistance CFU isolation on multiple antibiotic and antibiotic-free plates
Phage Contamination Plate bacterial cells on media containing no antibiotics
DNA Homogeneity Densitometry analysis of EtBr stained AGE
Identity EtBr stained agarose gel electrophoresis
Restriction Digest EtBr stained agarose gel electrophoresis
Plasmid Identity Double Stranded Primer Walking Sequencing.
Plasmid Retention Antibiotic Typing
Plasmid copy number Report
Plasmid Passaging Stability Test
Test Item Test Method
Plasmid loss rate Agar plate colony counting
Plasmid restriction enzyme map Restriction enzyme digestion
Plasmid supercoil HPLC
Plasmid sequence Sanger sequencing (outsourced)
Culture purity Should exhibit typical Escherichia coli colony morphology, with colonies being creamy white, smooth, circular in shape, with well-defined edges, and no other contaminating bacteria growth.
Antibiotic resistance Should meet the requirements
Plasmid copy number qPCR
Phage examination Negative
plasmid QC

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5. GMP AAV Quote Request
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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.

CDMO Plasmid Flyer

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