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AAV CDMO Services

Our Services

PackGene offers high quality AAV vector packing services suitable for discovery phase projects through clinical trials. Our highly experienced team is capable producing non-GMP AAV at the highest efficiency, as well as GMP-grade AAVs of the highest quality. GMP-services include GMP cell banking, process development, GMP-compliant AAV manufacturing, GMP production line set-up, processing and assay transfer, and IND pharmacological documentation.

Our AAV packaging services are fully customizable, and our experienced technical team will work with you to ensure that our services meet your diverse needs.

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GMP Cell Banking

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cGMP Process Development

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AAV GMP-like Manufacturing

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AAV cGMP Manufacturing

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AAV One-stop solution

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Our Platforms


293 AAV High-yield Production Platform

PackGene’s proprietary π-Alpha 293 AAV High-yield Platform uses uniquely designed RC plasmid in the triple-plasmid transfection system to increase AAV production by 3 to 8 times for various AAV serotypes. This technology is paired with both in-process upstream and downstream QbD optimizations to increase total AAV yield up to 10 fold. A single batch of AAV production delivers up to 1E+17vg virus particles, which is enough to meet the needs of most clinical and commercial level of AAV production.

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Plasmid DNA High-yield Production

PackGene’s proprietary π-Omega Plasmid DNA High-yield Platform increases plasmid yield by more than 3 times through plasmid backbone modifications. Production scale can reach up to 200L, and single-batch production yields can reach up to 100 grams. As a key raw material in AAV production, plasmid DNA cost reduction greatly reduces AAV production cost while simultaneously meeting the growingly plasmids demand in the mRNA based therapeutics.

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AAV Serotype Screening Platform

With its proprietary π-Icosa High-capacity and High-precision AAV serotype screening platform PackGene aims to identify tissue-specific and maximally infective AAV serotypes for clinical trial development. High infectivity and tissue specificity can ultimately reduce the dosage and production cost of AAV-based gene therapies while simultaneously increasing safety and efficacy.

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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.