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AAV One-stop Solution

AAV

  • As the gene and cell therapy landscape has expanded there has been a subsequent expansion in the need large-scale production of GMP-grade AAVs that meet regulatory filing standards. PackGene aims to meet this need across phases of the gene and cell therapy lifecycle including PI initiated clinical trials (IIT), to Investigational New Drug (IND) filings, to Phase I-III clinical trials, and large-scale commercial production of GMP-grade AAV.

    Using our proprietary platforms and technologies PackGene provides mass-production services for GMP-compliant AAV, as well as GMP production line set-up, virus processing and assays, and IND pharmacological documentation for processes ranging from the upstream rAAV generation to the downstream isolation and purification. We also ensure that our AAV manufacturing services comply with GMPs and all applicable regulatory and required standards for IIT and IND applications.

    Note: PackGene’s FDA and EMA compliant AAV GMP manufacturing facility (~2000m²) begin production in 2021. For more information, please contact us.

     

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AAV One-stop Solution

PackGene’s proprietary π-Alpha 293 AAV High-yield Platform utilizes a specially designed RC plasmid within a triple-plasmid transfection system, significantly boosting AAV production across different AAV serotypes.

We offer a comprehensive, one-stop solution for all aspects of AAV production, including plasmid and AAV manufacturing. Our extensive quality control testing panels and strict quality assurance measures guarantee the highest standards. We provide off-the-shelf materials, such as RC and helper plasmids, in a cost-effective manner. Our methods are optimized, and our customized analytics are tailored to meet your specific requirements, ensuring efficient and reliable outcomes.

Our GMP Facility

  • 2 GMP Manufacture Sites
  • 6 GMP AAV suites · 121,000sqf · 50~2000L
  • 2 GMP plasmid suites · 11,000 sqf · 5~400L
  • 60+ AAV analytical panels in house
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Proven Track Records

  • 50+ GMP batches delivered

  • Scales from 25-200L

  • IND-approved cases in 2023, 2024

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Confidentiality Commitment from PackGene:

The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.

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