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Aseptic Fill & Finish

  • PackGene provides aseptic filling and packaging services for AAV gene therapy products. All procedures are thoroughly documented and quality-controlled in accordance with GMP requirements for Phase I/II/III clinical manufacturing. We offer options for AAV in tubes or vials as per customer requests, helping our clients to save time and expenses through our one-stop for all service style. We can accommodate customized requests for aliquot size, AAV titer per aliquot, vial material, and order size.

    Note: PackGene’s FDA and EMA compliant AAV GMP manufacturing facility (~3000 square meter) start to begin production in 2021. For more information, please contact us.

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Service Details

Aseptic Filling Services Capacity Fill Volume
Manual Up to 900 vials/day 50 ul-2 ml
Semi-automated Up to 2,000 vials/day 1ml-100ml
Automated Up to 4000 vials/batch 0.5ml-6ml

Regulatory Compliance Features

  • Grade A/BSC environment

  • Meets FDA requirements for Phase I/II/III clinical manufacturing

  • Three rounds of media fill qualification

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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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