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PackGene offers single batch fermentation at several volumes, including: 2L, 7L, 25L, 50L, and 200L. AAV yields for each of these production volumes varies across AAV serotypes. As an example, AAV9 is a medium to high-yielding serotype, and expected yields for AAV9 are as follows:

PackGene’s h293 cell bank is officially authorized for commercial use.

Reagents used for Gene Therapies should abide by all domestic regulations in the “Guiding Principles for Quality Control of Human Recombinant DNA Products” by the EDC. Under these standards Mycoplasma and endotoxin testing is required.

Visible foreign matter can be identified by visual inspection. According to pharmacopoeia general rule 0904, visible foreign matter in injections, ophthalmic liquid preparations, and sterile APIs can be visually observed under specified conditions . Visible foreign matter is usually derived from insoluble particles of a size or length is greater than 50μm.

Insoluble particles between 10μm and 50μm cannot be seen with the unaided eye and must therefore be detected by instrumentation. Insoluble particles identification is commonly carried out with an insoluble particle analyzer. According to pharmacopoeia general rule 0903, evaluation of the size and quantity of insoluble particles within materials to be delivered by intravenous injection (solution injection, sterile powder for injection, concentrated solution for injection) can be made according to the project nature.

The term rcAAV stands for replication-competent AAV. In most cases rAAVs are designed to be replication incompetent. Thus, rAAV samples should not contain rcAAV and regulations require negligible replication capability for GMP rAAV samples.

Successful transgene expression via rAAV infection relies on several factors beyond the functionality of the DNA vector. We therefore recommend that independent validation of transgene expression is performed for all packaged rAAV.

The current standard for determining infection titer is TCID50 (Median Tissue Culture Infectious Dose). In this assay we test the infection rates of rAAV sample serial dilutions in H5 cells. This initial test is then followed by qPCR detection of the rAAV genome.

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.