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Plasmid GMP-like Manufacturing

GMP-like plasmid DNA is a faster and more cost-effective alternative to GMP production, which can be produced in accordance with standard or customizable specifications. GMP-Source plasmid DNA can be used as an auxiliary or key raw material for the production of protein and virus candidates for clinical trials.

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Plasmid GMP-Like Product

 √      Single-use fermentation (20L to 200L)
 √      Ultra-filtration & AKTA ready purification system
 √      Quality Inspection
 √       Batch record, manufacturing summary report, CoA
Plasmid Quality control (or customized based on specific process)
Category Items Method
General Characterization Appearance Visual inspection
pH pH meter
Identity Restriction Digest Agarose gel electrophoresis
Plasmid Sequence Sanger Sequencing
Content DNA Concentration UV spectrophotometry(A260)
Purity UV Purity A260/A280 ratio
DNA Homogeneity HPLC
Impurity Residual Host Cell DNA qPCR
Residual Host Cell RNA Agarose gel electrophoresis
Residual Host Cell Protein ELISA
Residual Kanamycin ELISA
Safety Endotoxin LAL
Sterility Test Direct Inoculation Method
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