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 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 （~8000 square meter） is expected to begin production in 2021. For more information, please contact us: email@example.com
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|
- 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.