Aseptic Fill & Finish
PackGene provides aseptic filling and packaging services for AAV gene therapy products. All procedures are thoroughly documented and quality-controlled in accordance with GMP requirements for Phase I/II/III clinical manufacturing. We offer options for AAV in tubes or vials as per customer requests, helping our clients to save time and expenses through our one-stop for all service style. We can accommodate customized requests for aliquot size, AAV titer per aliquot, vial material, and order size.
PackGene’s FDA and EMA compliant AAV GMP manufacturing facility (~3000 square meter) start to begin production in 2021. For more information, please contact us.
Grade A/BSC environment
Meets FDA requirements for Phase I/II/III clinical manufacturing
Three rounds of media fill qualification
PackGene offers aseptic filling as per your request. Please provide your project details for a quote or technical recommendations from PackGene.
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.
Plasmids GMP Services
Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way
AAV GMP Services
Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies
PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.