Molecular Diagnostics Services, Inc.
A Contract Research Organization

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: 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.
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