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Aseptic Fill & Finish

PackGene provides aseptic filling and packaging services for AAV gene therapy products. All of our 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 by a 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: info@packgene.com

Interested in our AAV services? Please contact us for a free consultation or  submit a request for a quotation.
Aseptic Filling Services
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

  • Grade A/BSC environment
  • Meets FDA requirements for Phase I/II clinical manufacturing
  • Three rounds of media fill qualification
PackGene offers aseptic filling as per your request. Please provide your project details for a quote or technical recommendations from PackGene.