Plasmid DNA
Plasmid DNA development and manufacturing for viral vector and mRNA production
Applications
Plasmids can be used as ancillary or critical starting material for:
- AAV or lentiviral vector productions to be applied to the clinical manufacturing of gene and immuno-oncology therapies.
- mRNA manufacturing
- clinical manufacturing of biological drugs.
MANUFACTURING Highlights
- Starting from 1 mg batch size.
QUALITY Standards and Certifications
- Production and analysis are performed in ISO certified laboratories.
- Most relevant features of cGMP manufacturing are applied (e.g., traceability, document control and materials segregation).
- All the equipment for production and analysis are validated (IQ/OQ protocols).
- All the starting materials and single use components are certified as TSE-BSE free.
- Majority of analytical assays are performed in-house.
Anemocyte offers three distinct pDNA quality grades, each aligned with specific development and regulatory requirements. R&D Grade, High-Quality (HQ) Grade, GMP Grade.
From Cell Banking to Final Filling:
Our Plasmid DNA Workflow
- 1. Microbial Cell Banking: establishes a stable, validated cell source for consistent plasmid production.
- 2. Microbial Cell Culture: optimizes fermentation for maximum plasmid DNA yield through controlled growth.
- 3. Cell Lysis (RNAse Free): releases plasmid DNA while maintaining integrity in an RNAse-free environment.
- 4. Purification: utilizes chromatography to isolate high-purity plasmid DNA from impurities.
- 5. TFF/Formulation: concentrates and buffers exchanges the DNA, followed by custom formulation.
- 6. Final Filling: aseptic filling of the final product into sterile containers, ensuring quality.
