Seamless incorporation of single-use equipment allows maximum flexibility.

The customer established a state-of-the-art facility encompassing laboratories and manufacturing areas dedicated to the development and production of gene therapy products. Serving as the process integrator, ZETA delivered comprehensive EPCV services – Engineering, Procurement, Commissioning, and Verification – across key operational zones, including upstream and downstream processing, buffer and media preparation, and process development.

ZETA assumed full responsibility for project execution, encompassing project and engineering management, process and mechanical engineering, automation, and qualification.

The design of the multi-product facility must meet the need for maximum flexibility in equipment positioning. The connectivity of the SU equipment is an essential factor in ensuring the functionality of the system during changeovers. The production environment, especially the hose and tubing, EIC and automation systems, must be able to seamlessly integrate the SU components to ensure smooth and error-free production.

ZETA implemented a supplier-agnostic concept, integrating single-use (SU) equipment and connectors from various manufacturers. Compatibility with SU assemblies was thoroughly ensured, enabling full system functionality and production in line with the customer’s stringent standards.

To support multiproduct manufacturing, the pilot plant was designed with maximum flexibility in mind. It featured bioreactors, detergent treatment units, chromatography, and filtration systems. These were prefabricated as modular skids at ZETA’s workshop in Moravany. Following a successful Factory Acceptance Test (FAT), the system was delivered, installed, and commissioned at the customer’s site in Belgium.

The use of modular, mobile equipment assemblies allows for rapid adaptation to varying production needs. In the downstream process, for instance, filtration units of different sizes can be deployed to match specific product volumes, ensuring both scalability and efficiency.

ZETA developed well-structured routing concepts for SU tubing, ensuring safe, operator-friendly hose management. This approach not only enhances the facility’s visual organization but also eliminates trip hazards, contributing to a safer and more efficient working environment.