Plasmid DNA Production    

Large-scale, high quality plasmid DNA production under GLP conditions is available. Whether it’s a large sample size, or large amounts (up to milligram quantities) of individual plasmid DNAs that is required, we can meet these needs. The quality of the final product plasmid DNA is suitable for many down-stream applications including DNA reference standards, transfection assays, or DNA-based antibody production.

As per GLP, the service includes a project protocol with all procedures covered by SOPs from sample receipt to data delivery. A Study Director is assigned to each project to oversee all steps from sample receipt through final data delivery including adherence to each SOP. Additionally, each project will be reviewed by our independent QA Unit personnel to ensure the quality and integrity of the study.


 Plasmid DNA production service includes:

- Purification of plasmid DNA with resin based methods
- Sample and final product identity verification with restriction digest and DNA sequencing
- Sample and final product quality and quantity assessed with UV spectroscopy and agarose gel   electrophoresis
- Aliquot of final product into desired any concentration and shipping to any destination

 Delivery of a comprehensive Final report that can be incorporated into any regulatory agency’s   application and includes:

- DNA production procedure and strategy
- Sample and final product identity verification data (hard copy and CD)
- A quality assurance (QA) statement


 Data archival at the study’s conclusion that includes:

- Original sample
- Copy of the final protocol and any amendments
- Laboratory notebooks containing all raw data
- All computer-generated data
- Study correspondence
- Statistical records
- Copy of the final report
- An original signed protocol, an original signed report, the study correspondence and all raw data   captured on durable media