Optimize and manufacture even the most difficult plasmids
Our process development team is committed to developing plasmid processes to ensure the ideal balance between purity and yield for early clinical through commercial production. Leverage Akron to optimize and manufacture even the most difficult plasmids.
Details:
- PD Laboratory designed to meet ISO 7 (Controlled non-classified)
- Assessment & determination of CQAs & CPPs
- Transformation, strain selection, clone selection, and growth conditions optimization (shake flask & Ambr250®)
- 5L & 30L fermenters for production
- Chromatographic purification (ÄKTA™ Avant & pilot 600)
- Research cell bank generation
- Product characterization and QC release testing
- Process development report