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  • 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.

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

見積もり依頼

PackGene による機密保持の約束:

ご提出いただいた情報は厳重に機密に保持されます。PackGene は、第三者または関係者に開示することは一切なく、提出者からの要請に基づき、機密保持条件下でプロジェクト評価や進捗レポートにのみ使用します。

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