LeanBioProBiotechnology - Therapeutics and Diagnostics
Leanbio is a start-up company founded in June 2014 By Dr Andreu Soldevila Fàbrega, who together with Albert Font Ingles lead the Lean Bioproduction project, which aim is to provide solutions for the development of biologic products, mainly focused in Biopharma sector by providing straightforward approaches to reduce time to market of New Biological Entities and Biosimilars.
Leanbio develops proprietary Technology and proprietary products, provides Biological Products development and manufacture for third parties following a QbD approach and full compliance with Regulatory Agencies.
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:
1. Feasibility platform
High throughput approach for candidate selection
Fast pace platform approach for Cloning, Fermentation, Purification and characterization
2. Development platform
Cell banks: Cell line development and RCB
Process development: USP and DSP
3. Formulation and Analytical development:
QTPP, Specifications, IPC/IPT, Test certificates, Stability studies
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4. Cell banks
MCB and WCB
5. Manufacturing platform
Pilot scale: Up to 300L scale
Industrial scale: Up to 1000L scale
Quality Control: specifications, batch testing,Certificate of analysis