Plasmid
Production Platform
Plasmid
Production
Platform
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Plasmid Strain Bank

Strain Bank Quality Control Assays

Serial Number Assay Method
01 Cell Bank Viability（CFU/mL） Plate Count Analysis
02 Host Cell Identity Gram Stain Analysis
03 Appearance Visual Testing
04 Biochemical ID Biochemical Confirmatory Test
05 16S rDNA Sequence Sequencing
06 Host Cell Purity TSA/SDA
07 Antibiotic Resistance CFU Isolation on Multiple Antibiotic and Antibiotic-free Plates
08 Digestion Profile AGE
09 Plasmid Retention Antibiotic Typing
10 Copy Number qPCR
11 Plasmid Identity Sequencing
12 Phage Test Double-Layer Agar (DLA)
13 Mophology TEM
14 Whole Genome Sequencing (WGS) Sequencing

GMP Plasmid
Manufacturing Process

pDNA Quality Control Assays

Serial Number Assay Method
01 Appearance USP <631> Visual inspection
02 Concentration A260 UV Spectrophotometry
03 pH USP <791> pH
04 Identity AGE
05 A260/A280（Purity） USP <509> UV Spectrophotometry
06 DNA Homogeneity（%） HPLC/CGE
07 Residual Host Protein USP <1132> ELISA
08 Residual Host Genomic DNA USP <509> qPCR
09 Residual Host RNA HPLC/qPCR
10 Endotoxin USP <85> Kinetic Chromogenic LAL
11 Sterility USP <71> Direct Inoculation
12 Mycoplasma Contamination qPCR
13 Sequencing Sanger