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