GLP-Compliant Plasmid Prep Services
Save valuable time and resources by outsourcing Good Laboratory Practices (GLP)-compliant plasmid DNA preparation to Azenta Life Sciences, formerly GENEWIZ. Performed in our state-of-the-art GLP facility, Azenta’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
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. Azenta 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.
GENEWIZ ACCEPTS THE FOLLOWING STARTING MATERIALS
DNA (≥100 ng in water or TE)
Glycerol stock cells (≥200 µl frozen stock)
