Non GMP rAAV and Plasmid DNA Services

Recombinant AAVs (rAAVs) are the most promising vectors because they transduce dividing and quiescent cells, have long-term gene expression in vivo, low toxicity and inflammation in target tissues, and can have broad tissue tropism.

Avirmax CMC, Inc produces AAVs packed in both insect Sf9 and mammalian HEK293 cell platforms, and we have developed superior technologies to ensure the quality of our AAV products in terms of titer, purity, potency, and safety.

We provide our clients with multiple serotypes of vectors to meet your research needs.

Baculovirus-based Platform

Avirmax CMC, Inc. Sf9 production system utilize the Bac-to-AAV technology to generate rAAVs produced using two recombinant baculoviruses (rBVs), helper-free system. One of which carries Rep and Cap genes which are responsible for gene replication, packaging and AAV protein sell formation. The other baculovirus contains gene of interest (GOI) together with ITR sequences which are responsible for viral genome packaging. The rBVs are separately generated from baculovirus shuttle vectors(bacmids) contains the GOI and Rep-Cap expression cassettes.

FIG. The samples of In-house rAAV
Yield of Final Purified Product (AAV2* indicated an engineered capsid)
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Avirmax CMC, Inc, customizes the AAV packaging service based on your specific need starting from subcloning your gene of interest into our baculovirus shuttle vector to generate the bacmids for AAV packaging, we use both Cscl ultracentrifugation and chromatographic processes to purify rAAVs. We offer a wide selection of analytical methods for rAAV characterization and quality assessment.  The purified rAAVs can be safely applied to in vitro and in vivo research goals.

The advantage of Sf9 platform:

(1) High Yield to 1E+15 vg/L per batch.

(2) Robust, simple and cost-effective manufacturing process ease of scale-up of large quantity of production.

(3) Higher pathogen safety assurance for gene therapy products than mammalian cell culture systems.

Non GMP rAAV and Plasmid DNA Services

HEK293-based Platform

Avirmax CMC Inc. also have launched rAAV production using HEK293 cell suspension cell line utilizing transient transfection method with three plasmids: (1) transgene plasmid DNA carrying a transgene and ITRs for viral genome replication and packaging; (2) the Rep/Cap plasmid DNA encoding rAAV capsids and regulatory proteins for AAV packaging; (3) the helper plasmid containing the genes from adenovirus, which is responsible for regulation of AAV replication.

Our HEK293 AAV production service starts from a transgene plasmid preparation (DNA maxiprep) to triple-transfection to generate AAVs.  The production process without subcloning procedure simplify the production process and shorten the turnaround time by half. The AAVs are purified by Cscl ultracentrifugation and chromatography technologies, the exceeded quality of AAVs can satisfy for your in-vivo and in-vitro researches.

Advantage of HEK293-based platform:

(1)Simpler and easier manipulation process

(2)Shorter turnaround production time (~2-3 weeks)

(3)Easy to scale-up

We offer various production scales starting from 5E+12 vg, and scale up, please choose the desired quantity in the order form, or specify the amount in the message.

Testing and Assays

Avirmax CMC,Inc. provides high quality AAV packaging service which satisfies both the academic and Industry’s needs. We have been dedicated to develop the technologies to improve the AAV purity, yield, potency and safety. Our AAVs are quantified with high QA/QC standards to ensure the efficiency and safety of our products. We also provide full range of AAV analytical development service base on your need.

Standard Qualification methods included in the Non-GMP AAV packaging service

• ddPCR-AAV-genome quantification
• SDS PAGE-AAV purity
• AAV Genome DNA Agrose Gel
• AAV sequencing-AAV Identity

Additional Available Services Upon Request

• TCID₅₀ Assay
• ELISA Assay
• Host Cell DNA Assay
• Host Cell Protein Assay
• AAV Genome DNA Integrity Assay
• HPLC
• Dynamic Light Scattering (DLS)
• Stability Testing
• Aggregation Assay
• Endotoxin Test

To inquire Analytical Development, please fill the request form