Leanbio Pro Opens New Manufacturing Facility to Expand its Production Capacity in Barcelona, Spain

Introduction:

Leanbio opens new GMP facilities to expand its production capacities in Barcelona, Spain.

Features:

The site is planned with an area of 4,000 square metres. The new facility will house developmental and quality control laboratories, pilot plants, commercial production lines, and various services including cell banking, upstream processing, downstream processing, and GMP batch release.

The facility will include three GMP lines dedicated to mammalian cells, microbial cultures, plasmid DNA, and mRNA for advanced therapies. 

These lines will have a supply capacity, starting at 2000 litres initially, and will adhere to regulatory standards set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

The facility comprises three distinct segregated zones for the production of proteins and nucleic acids:

• Manufacturing utilising microbial expression systems, with a scale of up to 1000 litres.
• Manufacturing utilising mammalian expression systems, with a scale of up to 2000 litres.
• Manufacturing of plasmid DNA at a scale of up to 50 litres.
• Manufacturing of mRNA at a scale of up to 50 litres.

Construction is currently underway, and the facility is scheduled to become operational in the first half of 2025.

Specifications:

Name    Leanbio Pro
Type      New Construction
Year      2025