Leanbio technological platforms are designed to provide the desired amount of bioproduct with appropriate technical, documental and regulatory approach according to project and product life cycle.
Leanbio’s proposal is to have a flexible approach to help clients develop the products according to their needs, using a Patent free approach, minimizing cost and time to market.
Leanbio platforms correspond to:
- Feasibility platform
- High throughput approach for candidate selection
- Fast pace platform approach for Cloning, Fermentation, Purification and Characterization
- Development platform
- Cell banks: Cell line development and RCB
- Process development: USP and DSP
- Formulation and Analytical development:
- QTPP, Specifications, IPC/IPT, Test certificates, Stability studies
- Manufacturing platform
- Cell banks: MCB and WCB
- Pilot scale: Up to 300L scale
- Industrial scale: Up to 1000L scale
- Quality Control: specifications, batch testing,Certificate of analysis