Leanbio

Based in Barcelona, Leanbio operates as a Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical products. Founded in June 2014 by Dr. Andreu Soldevila Fàbrega, the company aims to expedite the market entry for New Biological Entities and Biosimilars. Dr. Soldevila, who serves as CEO, brings over two decades of experience in biologics development and co-founded the company with a vision to apply lean manufacturing principles to bioproduction. His extensive academic background includes a Ph.D. in Biology and Master's degrees in Biotechnology, Microbiology, and Genetics. Albert Font Ingles is also mentioned as a co-leader of the initial project and currently serves as a CEO.

Leanbio functions on a dual business model, providing services to third parties and engaging in co-development projects. The firm caters to a global client base, ranging from startups to large multinational corporations, within the pharmaceutical and biopharmaceutical sectors. Its revenue is generated by offering comprehensive, end-to-end services covering the entire lifecycle of a biologic product, from gene development to final formulation and manufacturing. This integrated approach is designed to reduce costs and development timelines for its clients.

The company's core services encompass the development and manufacturing of recombinant proteins, antibodies, plasmid DNA (pDNA), and messenger RNA (mRNA). Leanbio utilizes proprietary, patent-free technological platforms for strain and cell line development, process development (both upstream and downstream), and analytical and formulation development. The company has experience with over 100 candidate molecules, some of which are in late-stage clinical trials. To meet growing demand, Leanbio is significantly expanding its capacity with a new 4,000-square-meter GMP-certified plant in Sant Quirze del Vallès, expected to be operational in 2025. This facility will feature three distinct production lines for mammalian, microbial, and gene therapy applications, with manufacturing scales up to 2,000 liters.

Financially, Leanbio has secured significant investment to fuel its expansion. The pharmaceutical company Reig Jofre recently increased its stake to 24% through a €5.8 million investment, aiming for vertical integration of biopharmaceutical development and production. This investment is part of a broader strategy that has seen Leanbio raise a total of $6.28 million over several funding rounds, including support from the European Union. The expansion has also been recognized as a strategic project by Spain's PERTE for Vanguard Health initiative.

Keywords: CDMO, biopharmaceutical manufacturing, recombinant proteins, mRNA, biologics development, biosimilars, gene to vial, process development, cell line development, GMP manufacturing