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 Highlights
- 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.
- 1. Microbial Cell Banking
- 2. Microbial Cell Culture
- 3. Cell Lysis (RNAse Free)
- 4. Purification
- 5. TFF/Formulation
- 6. Final Filling
