GLP-Compliant Plasmid Prep Services

Save valuable time and resources by outsourcing Good Laboratory Practices (GLP)-compliant plasmid DNA preparation to GENEWIZ. Performed in our state-of-the-art GLP facility, GENEWIZ’s endotoxin-free DNA preparation services, including animal-free plasmid preparations, are FDA and EPA GLP compliant to accelerate pre-clinical development of therapeutics for clients in biotechnology, pharmaceuticals, and other industries. Our plasmid DNA can be used for the development of various biologics, including, but not limited to, monoclonal antibodies, cell and gene therapies, and viral vaccines. In addition, our GLP DNA products also act as internal controls for biomarker assays and kits.

GLP-COMPLIANT PLASMID PREPARATION PROCESS

1. Study Protocol Established

Development of client approved study protocols

2. Plasmid DNA Preparation

Plasmid preparation following established study protocol and validated SOPs

3. Plasmid Preparation QC

Sanger sequencing verification and restriction digest QC of purified plasmid DNA

4. Purified Plasmid & Study Report

Final product, Certificate of Analysis, and a detailed Study Report (details below)

ADDITIONAL SERVICE OPTIONS

Animal-Free Preparations

Upstream Gene Synthesis & Cloning

GLP Master Cell Bank Characterization

Features & Benefits

Scalable, customizable, GLP-compliant, endotoxin-free plasmid preparation service with client-approved protocols offers a complete solution to support your regulatory submissions.

State-of-the-art, dedicated GLP laboratories meet FDA and EPA guidelines to enable controlled samples, personnel, instruments, processes, and documents.

Stringent quality control based on your project needs with multiple reviews and established Standard Operating Procedures (SOP) to generate consistent results.

Established Quality Management System with oversight from independent Quality Assurance Unit guarantees data adheres to FDA and EPA regulations. GENEWIZ is available for audits.

Dedicated Study Director ensures a single point of contact, expert technical support, and consistent, transparent communication throughout the project.

Customized study reports include methods used, raw data, results, details on Quality Assurance oversight and inspections, GLP compliance statement, Certificate of Analysis (COA), and more where applicable.