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GMP Plasmid DNA Manufacturing

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.

Assay Method
Final Product Appearance Testing Visual Testing
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
DNA Homogeneity Densitometry analysis of EtBr stained AGE
Identity EtBr stained agarose gel electrophoresis
Restriction Digest EtBr stained agarose gel electrophoresis
Plasmid Identity Double Stranded Primer Walking Sequencing.
Cell Bank Viability CFU/mL plate count analysis
Host Cell Purity Trypticase Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA)
Detection of Lysogenic Bacteriophage Plated in the presence of Mitomycin C
Plasmid Retention Antibiotic Typing
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
Appearance Visual inspection
Concentration UV Spectrophotometry
DNA Homogeneity Densitometry analysis of EtBr stained AGE
Endotoxin Kinetic Chromogenic LAL
Identity EtBr stained agarose gel electrophoresis
Plasmid Identity Double Stranded Primer Walking Sequencing
Residual Host Genomic DNA Quantitative PCR
Residual Host Protein Micro BCA
Residual Host RNA SYBR Gold stained agarose gel electrophoresis
Restriction Digest EtBr stained agarose gel electrophoresis
Sterility USP <71> Direct Inoculation

Sterility Validation

(Bacteriostasis/ Fungistasis)

USP <71> Direct Inoculation
Mycoplasma Contamination Quantitative PCR
Osmolality USP <785>
pH USP <791>
Bioburden Testing for total aerobes, anaerobes, sporeformers and fungi
Conductivity Conductivity Meter
Detection of Kanamycin ELISA