GMP AAV Packaging Plasmids

uBriGene offers off-the-shelf AAV Rep/Cap plasmids covering multiple serotypes, including AAV1–AAV13. Custom Rep/Cap and gene-of-interest (GOI) plasmid options are also available for programs requiring a specific capsid or vector design.

AAV Rep/Cap plasmids provide the Rep proteins and capsid functions required to produce the selected AAV serotype, while helper plasmids provide additional functions needed for AAV vector production. uBriGene’s GMP-grade AAV Rep/Cap and helper plasmids are manufactured and quality-released for use in GMP AAV manufacturing.

Yes. uBriGene’s GMP AAV Rep/Cap and helper plasmids can support AAV programs from preclinical development through clinical manufacturing, subject to the applicable material, process, quality, and regulatory requirements for the intended stage. Using qualified GMP plasmids can also help maintain continuity as an AAV program progresses toward clinical manufacturing.

uBriGene’s QC panel for GMP AAV Rep/Cap and helper plasmids can include appearance, pH, concentration, identity, target-sequence analysis, purity, supercoiled-plasmid ratio, residual E. coli DNA/RNA/protein, endotoxin, and sterility. Target-sequence analysis may be outsourced where applicable.

uBriGene’s AAV plasmids are supported by FDA Drug Master File (DMF) #28890. A DMF can provide CMC information that a sponsor may reference in an appropriate regulatory submission. The DMF itself does not guarantee faster FDA review or IND clearance. uBriGene can also provide applicable regulatory documentation and manufacturing support for AAV programs.

uBriGene reports AAV yields of approximately 1 × 10¹³ to 1 × 10¹⁴ VG/mL when using its AAV production platform, depending on the serotype and production conditions. Actual vector yield can vary with the vector construct, serotype, production cell line, process parameters, and downstream manufacturing process.

Yes. uBriGene’s off-the-shelf AAV Rep/Cap and helper plasmids are available royalty-free for applicable AAV manufacturing programs.

uBriGene’s off-the-shelf AAV plasmids are typically available for shipment within 1–2 weeks after order confirmation, subject to product availability and order requirements.

Yes. uBriGene’s GMP AAV Rep/Cap and helper plasmids are used within its scalable AAV manufacturing platform. The broader AAV manufacturing platform supports production from 50 L to 2,000 L, with manufacturing scale established according to the serotype, vector construct, process, and development stage.

Yes. uBriGene provides custom AAV Rep/Cap and helper plasmid development and GMP manufacturing in addition to its off-the-shelf AAV plasmid portfolio. Custom programs can be configured according to the required capsid, vector design, and manufacturing requirements.

AAV Rep/Cap selection depends on factors such as target tissue, desired tropism, route of administration, vector design, and available preclinical data. uBriGene offers Rep/Cap plasmids covering AAV1–AAV13 and can support custom Rep/Cap development when a specific capsid is required.

Yes. uBriGene can evaluate sponsor-provided AAV plasmid designs for compatibility with its manufacturing platform. Where additional optimization or manufacturing development is required, uBriGene can support process development and GMP plasmid manufacturing according to the program requirements.