GMP-Source™ Plasmid DNA

GMP-Source™ Plasmid DNA

A faster and cost-effective alternative to GMP production, GMP-Source™ plasmid DNA can be manufactured to standard or customizable specifications. Adopting the most relevant features of cGMP manufacturing, including traceability, document control and materials segregation, GMP-Source plasmid DNA can be used as an ancillary or critical raw material for producing protein and viral candidates used in clinical trials.

Accompanied by a comprehensive manufacturing summary report suitable for regulatory submissions, we deliver high-quality products to fit your GMP-Source project.

Product Details

  • E. coli Master Cell Bank Generation
  • Shake Flask or High-Density Fermentation
  • Alkaline Lysis
  • Chromatographic Purification
  • Quality Oversight
  • Manufacturing Summary Report, TSE/BSE Statement

Cell Bank Quality Control Assays

AssayMethod
Host Cell Identity Bacterial colony morphology
Lytic Phage Contamination Plate bacterial cells on media containing no antibiotics
Host Cell Identity Gram stain analysis
Antibiotic Resistance CFU isolation on multiple antibiotic and antibiotic-free plates
Cell Bank Viability CFU/mL plate count analysis
DNA Homogeneity Densitometry analysis of EtBr-stained AGE
Identity EtBr-stained AGE
Restriction Digest EtBr-stained AGE
Plasmid Identity Double-stranded primer-walking sequencing
Host Cell Identity API 20E test kit
K12 Strain ID Zone of inhibition with L-Valine
Host Cell Identity 16S rDNA sequencing
Host Cell Purity Trypticase Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA)

Plasmid DNA Quality Control Assays

ABS 260/280 Ratio PurityUV Spectrophotometry
Bioburden Testing for total aerobes, anaerobes, sporeformers and fungi
Appearance Visual inspection
Concentration UV Spectrophotometry
DNA Homogeneity Densitometry analysis of EtBr-stained AGE
Endotoxin Kinetic Turbidimetric LAL
Identity EtBr-stained AGE
Mycoplasma Contamination Quantitative PCR
Osmolality Osmometer
pH Potentiometric
Plasmid Identity Double-stranded primer-walking sequencing
Residual Host Genomic DNA Quantitative PCR
Residual Host Protein Micro BCA
Residual Host RNA SYBRGold-stained agarose gel electrophoresis
Restriction Digest EtBr-stained AGE
Sterility USP <71>
Sterility Validation (Bacteriostasis/ Fungistasis) USP <71>
Volume in Container USP <1>
Particle Matter in Injections USP <788>