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