GMP Plasmid DNA

GMP Plasmid DNA

Driven by a comprehensive quality assurance process, we produce GMP plasmid DNA in segregated ISO-classified manufacturing suites ensuring the highest quality products with each and every order. Combined with dedicated project management and client-specific batch records, we work closely with our clients to provide customized GMP plasmid products.

Our full GMP fermentation capacity ranges from 10 to 1,000 liters. This allows us to offer a complete spectrum of plasmid DNA services, spanning from early research to commercial supply.

Product Details

  • Screening for Optimal Growth
  • E. coli Master and Working Cell Bank Generation
  • Development and Engineering
  • Shake Flask or High-Density Fermentation
  • Alkaline Lysis
  • Chromatographic Purification
  • Quality Oversight and Process Control
  • Manufacturing Summary Report, TSE/BSE Statement
  • Client-Specific Master Batch Records

Cell Bank Quality Control Assays

In addition to the assays below, we can provide custom developed procedures to meet your requirements.

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

In addition to the assays below, we can provide custom developed procedures to meet your requirements.

Assay Method
ABS 260/280 Ratio Purity  UV 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>