Plasmid DNA (Research, High Quality, And GMP) Solutions
Plasmid DNA is a critical material for scaling many advanced cell and gene therapies. Charles River offers custom plasmid production to accelerate your product’s timeline and increase manufacturing efficiency.
Contract Development and Manufacturing Services and Products
We offer plasmid DNA CDMO solutions with centers of excellence in the UK, providing a variety of products and services from early discovery through commercialization including off-the-shelf to custom plasmid products and manufacturing services comprised of three grades – Research, High Quality (HQ), and GMP, with off-the-shelf timelines from 48 hours and custom production from five weeks.
Available Services and Products
Molecular Biology
- Plasmid synthesis
- Custom construction and engineering
- Clone screening
Process Development and Scale Up
- Fermentation and media development (animal component free)
- Evaluation of productivity and optimisation of harvest point
- Lysis optimisation (primary recovery)
- Purification development and optimization
- DoE (Upstream and Downstream)
Analytical Development and Qualification
- Assay transfer, development and validation
- QC release testing (BDS/DP)
- Product characterisation
- Stability studies: drug substance and drug product
Quality Assurance and Regulatory Support
- Three Qualified Persons (QP) (Keele, UK)
- Fully compliant with European Clinical Trials Directive 2001/20/EC and FDA standards (Keele, UK)
- Authorised by UK MHRA for the GMP production of Investigational Medicinal Products (Keele, UK)
- Support for CMC filings
- QP release (Keele, UK)
- Shipment to clinical trial sites
Project Management
- Dedicated project manager
- Cross-functional project teams
- Detailed timeline planning and milestone tracking
Off-the-Shelf HQ Viral Vector Packaging Plasmids
- Premanufactured - 48 hour turnaround
- High Quality grade for viral vector GMP production
- GMP quality control (QC) testing
- Kanr resistance
- Animal component free production
Plasmid DNA Manufacturing Comparison
Click to enlarge