JGL, a CDMO based in Rijeka, Croatia is investing $64 million to expand its sterile production capabilities. Luka Luksic, Director of CMO and Technology Transfer, JGL, detailed the expansion at the DCAT Member Company Announcement Forum at DCAT Week.  

The expansion, which began in 2020 and is expected to conclude by 2026, involves adding new production lines and infrastructure to the existing site, which has a focus on sterile filling technology for products in ophthalmology, cold and flu, and dermatology.  

The project includes three new production lines: one for sterile sprays, one for sterile drops and sprays, and one for bag-on-valve aerosols. A new packaging line will also be included and will connect to the current centralized palletization system. Within a building constructed in 2015, 25,000 square feet of cleanroom space, compliant with GMP, is being equipped. The sterile drops and sprays lines will each operate at 10,800 units per hour, with one starting in 2025, while the bag-on-valve aerosol line will run at 4,800 units per hour. These additions will increase production capacity for sterile products. 

A pilot plant, certified under EU GMP standards, is also part of the expansion. It will produce sterile solutions, suspensions, and emulsions for clinical and registration batches. The plant operates at 3,600 units per hour, with an annual capacity of 5 million units, and supports both GMP and non-GMP operations. This facility will focus on the development and production of sterile products required for clinical study and regulatory purposes. 

The project further includes integrated research and development (R&D) and quality control (QC) laboratories, covering 26,000 square feet. These labs employ 71 QC staff and 42 R&D personnel, conducting 63,000 QC analyses each year. Collaboration occurs with external entities, including the University of Rijeka Faculty of Biotechnology and Drug Development and specialized laboratories, to support testing and development activities. 

A robotized logistics and distribution center is being built, featuring a high-bay warehouse maintained at 70°F with an automated capacity of 17,500 pallets. A cold chamber, kept between 36°F and 46°F, will hold 300 pallets. The warehouse area will expand by 15,500 pallets, following GXP regulations. 

Additional infrastructure includes new office space, an auditorium with a capacity of 350 people, a pharmacy museum, and an employee restaurant and café.