High quality plasmids are widely used across multiple therapeutic avenues including gene and cell therapies (GCT), mRNA/DNA Vaccines, and Nucleic acid drugs among others. PackGene provides plasmid manufacturing services that are ideal for any phase of the drug development cycle from basic discovery research to commercialization at any scale.
PackGene has processes in place for end-to-end design, production, and manufacturing of new or existing plasmids. We also offer full process development support for plasmid-specific projects, which includes USP, DSP, and analytical services.
|Plasmid Production Service||Scale||Applicaton|
|Research-grade Plasmid||100ug-1g||In vitro or preclinical studies|
|GMP-Source Plasmid||>500mg or inquiry||Preclinical or clinical phase I|
|GMP Plasmid||>500mg or inquiry||IND or clinical phase I-III|
GMP Bacteria Banking
Plasmid Non-GMP Manufacturing
Plasmid GMP-like Manufacturing
Plasmid cGMP Manufacturing
Plasmids One-Stop Solution
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.