GMP Plasmid DNA

Overview

PackGene provides GMP-grade plasmid manufacturing services for cloning, amplification, and purification of plasmids to support subsequent GMP-grade AAV production as well as other applications. Our segregated ISO-classified plasmid manufacturing suite (10,700 ft²) has been fully operational since September of 2021. We provide GMP-grade plasmid vector cloning, amplification, and purification services and cover large-scale fermentation, material isolation, full traceability documentation control, and comprehensive quality control assays. Our expert team will work with you to design a customized project proposal that meets your specific needs.

Plasmid cGMP Product Features
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Bacteria bank generation

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Quality control inspection and report

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Single-use fermentation (50L to 200L)

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Batch record, manufacturing summary report, CoA

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Ultra-filtration & AKTA ready purification system

Production Details

PackGene plasmid process GMP
(Phase I & II)
GMP
(Phase III and commercialization)
Clone screening
Growth condition optimization
High density fermentation
Alkaline lysis
Chromatographic purification
Antibiotics free
Consistent manufacturing process
Instrument calibration/validation Validation Validation
COA & CoC COA, CoC COA, CoC
TSE/BSE

Manufacturing Facilities
Quality Control
Test Methods
Appearance Visual inspection
A260:280 Ultraviolet-visible spectrophotometry (A260/A280)
Homogeneity HPLC
Restriction Analysis Agarose gel
Residual RNA SYBRGold
Residual E. coli DNA qPCR
Endotoxin LAL
Bioburden Testing Direct inoculation
Sequencing Sanger
Antibiotics Free Production
Residual Host Protein HCP ELISA
Animal Free Production*
Mycoplasma Contamination qPCR
Material Archiving
pH Potentiometry
Kan ELISA
Sterility
Osmolality

plasmid QC
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

Contact Us

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Request A Quote
5. GMP AAV Quote Request
Confidentiality Commitment from PackGene:
The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.
Have you selected your candidate for gene therapy? (Optional)
Have you completed preclinical research? (Optional)
Please select one or more GMP services you need *

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.

CDMO Plasmid Flyer

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