GMP AAV Manufacturing – Clinical Grade

PackGene delivers end-to-end GMP AAV manufacturing as a leading CDMO partner for gene and cell therapy programs worldwide. We support every stage of your development—from preclinical research to Phase I/II/III clinical trial and commercial manufacturing. Our robust GMP capabilities and innovative facilities make us the preferred choice for biotech and pharma clients seeking reliable AAV contract manufacturing, lentiviral vector services, and GMP plasmid supply.

With our proprietary high-yield platforms and scalable production systems, PackGene offers fully integrated services, including:

• Custom Process Development & Optimization: Upstream and downstream protocols tailored to client specifications for maximum viral titer and purity.
• Assay Development, Analytical QC & Characterization: Comprehensive testing covering identity, potency, purity, safety, and empty/full capsid ratio analysis—ideal for GMP vector batch release and regulatory submissions.
• cGMP Manufacturing & Batch Release: Dedicated GMP cleanrooms for clinical-grade AAV, lentivirus, and plasmid manufacturing—fully FDA/EMA/ICH compliant.
• Process Validation & Commercial Scalability: Seamless scale-up from small-volume pilot lots to commercial campaigns up to 2,000L, supporting IND/BLA filings and global therapeutic launches.
• cGMP QC Release Testing: 40+ validated analytical assays, including qPCR/ddPCR, SDS-PAGE, endotoxin, sterility, mycoplasma, bioburden—and full documentation for clinical trials.
• AAV Contract Manufacturing: One-stop service for custom serotype vector design, production, fill & finish, vialing, labeling, and shipping—all under GMP standards.
• Viral Vector Fill & Finish: Flexible vialing solutions, validated container closure integrity, and tailored packaging for IND, CTA, and commercial submissions.

PackGene’s advanced GMP facility is designed to make gene therapy and GMP AAV manufacturing accessible and affordable for biotech and pharmaceutical innovators worldwide. Featuring state-of-the-art multi-product production suites, our infrastructure enables scalable commercial manufacturing from 25L pilot production up to 2,000L campaigns for clinical trials and global supply. We utilize cutting-edge single-use technologies and modular cleanroom design to deliver high-quality, regulatory-compliant products - ensuring flexibility and contamination control for diverse gene therapy applications. Our expert team supports clients from research-grade development through full GMP clinical manufacturing.

Facility Highlights

• 10 GMP viral vector suites: Totaling 121,000 sq ft, supporting flexible production scale (25L–2,000L) for AAV, lentivirus, and other viral vectors.
• 2 GMP plasmid suites: 30,000 sq ft dedicated to high-yield plasmid manufacturing for gene therapy and vaccine programs (5–400L scale).
• 60+ in-house AAV analytical methods: Comprehensive QC and lot release testing, including identity, potency, purity, sterility, capillary electrophoresis, and full regulatory documentation.

PackGene’s GMP facility is purpose-built for CDMO services, supporting rapid tech transfer, custom viral vector fill & finish, and scalable production solutions tailored to your project needs—from discovery research to commercial launch.

PackGene delivers a truly one-stop, end-to-end AAV manufacturing solution powered by our proprietary π-Alpha 293 AAV High-Yield Platform. Our streamlined process accelerates project timelines, enhances cost-efficiency, and guarantees regulatory readiness for gene therapy and cell therapy developers.

We provide comprehensive support throughout the entire AAV vector lifecycle—including:

• Process & Assay Development: Custom protocols for vector engineering, process scaling, and analytical assay development to meet IND-enabling requirements.
• IND-Enabling Studies & Technology Transfer: Expert guidance, documentation, and rapid tech transfer for projects advancing toward clinical submission.
• GMP Production & Lot Release: Fully compliant GMP manufacturing, rigorous quality control, and validated batch release testing.
• Comparability & Stability Testing: In-depth comparability studies, stability testing for regulatory filings, and customized analytical development panels.
• In-House GMP QC Services: 60+ validated assays, supporting identity, purify, potency, and regulatory compliance.
• RC & Helper Plasmids for GMP: DMF-backed, off-the-shelf RC and helper plasmids tailored for efficient and risk-mitigated GMP viral vector production.

Our One-Stop AAV GMP Production Solution Includes:

• π-Alpha High-Yield Production Platform: Superior AAV productivity and scalability across all major serotypes—supporting research and commercial vector needs.
• GMP Plasmid Manufacturing: Scalable, regulatory-compliant supply of critical starting materials for gene therapy, vaccines, and vector production.
• GMP Analytical QC Services: Comprehensive in-house testing ensures the highest standards of quality, safety, and FDA/EMA/ICH compliance for every batch.

PackGene provides GMP-compliant aseptic filling and packaging services for AAV gene therapy products, supporting Phase I, II, and III clinical manufacturing requirements. Our flexible infrastructure accommodates a wide range of vial types, fill formats, and batch sizes—offering manual, semi-automated, and fully automated solutions for custom project needs.

• Customized Fill Volumes and Formats: We support diverse AAV titers, vial materials, and fill volumes with validated container closure integrity, ensuring product stability and regulatory compliance.
• Extensive Documentation & Quality Control: Every step is rigorously documented, traced, and QC-approved for FDA/EMA standards. Our aseptic processing excellence is demonstrated by 3× Aseptic Process Simulations (APS).
• Flexible Scale: From small pilot batches to large-scale commercial campaigns, PackGene’s fill & finish capabilities enable seamless transition across all clinical phases.

PackGene delivers efficient, GMP-compliant cell banking solutions designed to ensure regulatory readiness, reliability, and scalability for high-quality AAV manufacturing in both clinical and commercial settings.

Key Offerings:

• Master and Working Cell Banking: Solution for both adherent and suspension HEK293/293T cell lines, built for robust viral vector production.
• High-Yield Cell Line Screening and Banking: Comprehensive selection, genetic construction, and scalable expansion from pilot studies to commercial volumes.
• Client-Supplied Cell Line Support: Expert banking and documentation for customer-provided cell lines, customized to project specifications and regulatory requirements.

PackGene’s robust, traceable cell banks form a reliable foundation for successful gene and cell therapy production, supporting process integrity, regulatory confidence, and commercial scalability.