cGMP Process Development
Establishing a cost-effective, robust and optimized production process is essential for GMP AAV production. With PackGene’s advanced platforms and extensive experience we will efficiently optimize your production processes including upstream and downstream process development required for plasmid and AAV production. At PackGene we understand that each customer and each project may have unique processing requirements and our virologists and engineers are committed to deliver robust fermentation and purification processes based on your specific requirements.
The development of an efficient manufacturing process is critical for the Investigational New Drug (IND) phase through clinical phases. All of the materials needed for clinical trials must be produced efficiently, safely, and consistently – especially when atypical manufacturing conditions are required. Unfortunately, high quality process development often requires extensive experience and may be quite costly; thus proper process development may be overlooked by independent researches and startup companies where resources must be managed carefully. PackGene Process Development scientist have the experience needed to help you achieve consistent GMP production at a fair cost.
Proper Process Development at the early and middle product development stages can ultimately reduce costs for both clients and patients as large-scale production cycles are established. Starting your project with the help of PackGene’s GMP Process Development services will ultimately save time and cost. The time required for process development services may depend on the scope of your project and can range from weeks to a few months.
PackGene provides GMP process development services
Upstream process development including fermentation volume, expression, and materials, optimization.
Downstream process development including recovery, purification, and concentration optimization.
MP QC services including assay development related to fast service safety, potency, purity, and identity.
PackGene can provide cGMP AAV process development for your project. Please provide certain project details to get a quote or technical support 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.