GLP/GMP Grade Plasmid DNA Production Services

Our GLP/ GMP services are used for research projects that require large amounts of highly purified plasmid DNA including animal experiments, microinjection, formulation development and potency assays, and gene therapy studies. We provide plasmid produced in a GLP/GMP environment with full QC release testing, cell banking, cloning, transfection and other related services. MDS guarantees endotoxin and contaminant free DNA products for use in a variety of applications. The entire DNA process is summarized below:

• Selection of host strain and growth conditions
• High-cell-density fermentation
• Alkaline lysis, filtration, and plasmid purification
• Endotoxin-exchange chromatography
• Quality control testing

Anion-exchange chromatography is utilized for DNA purification to completely avoid the use of toxic substances such as phenol, chloroform, ethidium bromide, and cesium chloride. The production process will be free of any contamination, particularly toxic or antigenic substances meeting the following criteria:

CERTIFICATE OF ANALYSIS (Typical Example)

	Test	Specification	Results
Identity	Circular Plasmid	> 95% Circular	> 95% Circular
	Supercoiled	Predominant	Predominant
	Restriction Map (2 common enzymes)	Agreement with Predicted Fragment Size	Size of the restricted bands on 0.8% agarose gel are in agreement
Purity	A260/280 Ratio	1.7-2.0	1.83 ± 0.04
	RNA	Undetectable by Gel	Undetectable
	Endotoxin	(Based on 0.5 mg load) < 100 EU/mg by LAL assay	68 ± 10 EU/mg
Appearance		Clear, Colorless solution	Clear, Colorless solution
Concentration		As Individually Required	Ranging from 0.2 mg/ml to 5.0 mg/ml

MDS also offers direct support to set up in-house, large-scale DNA production. For more information about these services, contact our technical department.

Quotation - A price quotation is based upon evaluation of your project requirements.