Plasmid DNA is a critical raw material for advanced therapeutics including mRNA- and viral vector-based cell and gene therapies and vaccines. To support your therapeutic programs, the Catalent team has broad expertise in developing customized plasmid DNA manufacturing solutions, from plasmid R&D services to large-scale CGMP plasmid production. Catalent can help you with lead identification to support candidate selection and feasibility studies. Once leads are identified, our cell line, process, and quality control assay development services will help assure the plasmids will meet your preferred critical quality attributes.
Our plasmid DNA services include:
- TSE-BSE-free CGMP-compliant process development and optimization
- Patented STABY® selection technology for plasmid stabilization
- CGMP cell banking
- Plasmid production from mg to 10+ g scale
- HQ Select™ high quality and GMP Ultra™ CGMP grade manufacturing
- Linearized plasmid for mRNA production
- QC qualified assays for plasmid release and cell bank characterization
- QA oversight
- Stability testing
With global facilities and clinical- through commercial-scale production capabilities, our team is ready to help define and deliver an integrated program from the development of the optimal plasmid and its manufacturing process to seamless transfer into viral vector production, including fill/finish and clinical supply services.