Plasmid cGMP Manufacturing
PackGene provides plasmid manufacturing under cGMP conditions for multiple treatments. Our new segregated ISO-classified plasmids manufacturing suite(2000m2) start to go into full operation in September, 2021.
Plasmid Manufacturing Facilities
PackGene’s fermentation scale ranging from 50L to 200L with single-use technologies. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain isolated manufacture conditions. We conduct full room changeover after finishing one batch.
Plasmid Quality control (or customized based on specific process)
|General Characterization||Appearance||Visual inspection|
|Identity||Restriction Digest||Agarose gel electrophoresis|
|Plasmid Sequence||Sanger Sequencing|
|Content||DNA Concentration||UV spectrophotometry(A260)|
|Purity||UV Purity||A260/A280 ratio|
|Impurity||Residual Host Cell DNA||qPCR|
|Residual Host Cell RNA||Agarose gel electrophoresis|
|Residual Host Cell Protein||ELISA|
|Sterility Test||Direct Inoculation Method|