Plasmid DNA
End-to-end plasmid DNA manufacturing at the Clinical Biotechnology Centre
Our Clinical Biotechnology Centre has been advancing cell and gene therapies for over 20 years. We provide end-to-end plasmid DNA manufacturing services for pre-clinical, clinical and commercial applications.
Our plasmid DNA service covers every stage of development, from process optimisation and manufacture to quality control (QC) testing and release. Our experienced team and validated processes can deliver up to 2g of plasmids for multiple applications.
Why work with NHS Blood and Transplant?
More than 20 years of experience
Since 1999, we have provided over 150 good manufacturing practice (GMP) grade plasmid DNA batches to support the development of novel cell and gene therapies.
We manufacture grade-appropriate plasmids for use in both pre-clinical and clinical stages of development. We support clinical trials through the provision, manufacture and release of GMP plasmids in our dedicated MHRA licenced cleanrooms.
End-to-end support
We can offer comprehensive support, including:
- manufacture of master cell bank
- optimisation
- plasmid manufacture and aseptic fill and finish
- QC testing
- product stability
- quality assured product release
Confidence in quality
Our team understands the complex regulations for cell and gene therapies, and can apply the relevant guidelines and knowledge to ensure safe and effective material is manufactured for your needs.
Our plasmid DNA manufacture process
Our process is streamlined, well-defined and backed by years of experience.
Process development
Initial process development activities help ensure product yield, purity and scalability as well as confirming GMP compliance. This reduces the risk of moving into full GMP production.
For plasmid DNA manufacture, this might include some combination of our standard protocols:
- cell line selection
- clone selection study
- optimisation of fermentation process
- end-to-end engineering batch
Master cell bank
The bacterial host cell line is transformed with the plasmid DNA, a colony is selected and a master cell bank produced and released to a defined specification.
Fermentation and harvest
Fermentation is established using a combination of shake flasks and fermenters. Bacterial cells are then lysed to release plasmid molecules.
Clarification and purification
Cell lysate undergoes a series of ultrafiltration and chromatographic steps to remove impurities.
Aseptic fill and finish
The product is filled under aseptic conditions using dedicated filling equipment and isolators.
Find out more about our fill and finish service.
Testing and release
Finally, the product undergoes QC testing, review and release by our quality teams.
Quality control
We offer plasmid DNA, grade-appropriate QC testing and stability studies. Whether you require a basic or complex analytical testing package, our team has the knowledge and experience to deliver.