Plasmids are widely used across multiple therapeutic modalities including applications in Gene and Cell Therapies (GCT), mRNA/DNA Vaccines, and nucleic acid drugs. PackGene provides a one-stop solution for GMP plasmid projects including bacteria banking, process development, analytical methodology development, plasmid manufacturing, plasmid stability testing, and document preparation.
Productivity
Two independent cGMP production lines with up to 200L production scale.
Quality
Isolated production lines, rigorous cleaning methods, and the use of disposable materials completely avoid cross-contamination.
Flexibility
Multiple scales and grades of production make it possible to complete your project with high efficacy at a reasonable price.
Professional
PackGene’s expert production team has more than 10 years of experience in plasmid manufacturing.
Advanced equipment
Single-use technology applied in both upstream & downstream processes. Fill & Finish under VHP isolator.
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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