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Plasmid cGMP Manufacturing

PackGene provides plasmid manufacturing under cGMP conditions for further AAV production or other applications, with the capability to manufacture customized plasmid vector cloning, amplification and purification under cGMP condition. The plasmid vector products meet requirements from preclinical research labs to clinical trials and commercial standards. Our GMP-compliant services cover plasmid vector cloning, amplification and purification at various scales including large-scale fermentation, material segregation, full traceability, document control, and a comprehensive range of quality control assays.

Note: PackGene’s FDA and EMA compliant Plasmid GMP manufacturing facility (~4000 square meter) is expected to begin production in 2021. For more information, please contact us: bd@packgene.com

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Plasmid Manufacturing Services

Plasmid manufacture can use your existing plasmid or we can construct a custom plasmid according to the customer requirements. We also offer complete upstream and downstream process development support for a specific plasmid project.

Plasmid Production Service Scale Applicaton
Research-grade Plasmid 100ug-1g In vitro or preclinical studies
GMP Plasmid >500mg or inquiry IND or Phase I-II clinical trials

Plasmid Manufacturing Facilities

PackGene plasmid production utilizes fermenters ranging from 1L to 50L with the single-use technologies and additional capacity planned for the future. Plasmid production are conducted in segregated and dedicated production suites. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain isolated manufacture conditions.
After finishing one batch, we conduct full room changeover, including cleaning of surfaces and non-disposable equipment, occurs prior to initiation of each new GMP plasmid project. We apply single-use materials for most of key procedures. The final fill and finish can be in a Biosafety Cabinet (BSC) with Grade-A cleanness in Grade B room between different plasmids.
PackGene can provide cGMP plasmid production for your project. Please finalize certain project details to get a quote or technical support from PackGene.
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