ZETA|Success Stories|Cutting-Edge Biotech Production Center
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Cutting-Edge Biotech Production Center

Ultra-fast track EPCMV project with substantial scope extension.

CAPEX project involving a high-tech production plant, QC lab and extensive infrastructure, delivered in only 25 months.

Full-scope EPCMV. Delivered in record time.

In just 25 months, a state-of-the-art biotech center with multiple production units was erected at the Loba biotech site near Vienna. The project involved adapting existing infrastructure and adding completely new buildings and production units. This was all accomplished in record time, adhering to stringent GMP-compliant production guidelines. ZETA served as the partner for full-scope EPCMV across all disciplines and for process equipment delivery.

The challenge

Loba Biotech, acting as a Contract Development and Manufacturing Organization (CDMO), was tasked with ensuring the global supply of a high-quality, indispensable drug within an extremely short time frame. They had to integrate new buildings into an existing production site while maintaining ongoing operations.

The project was highly complex with an ultra-fast track timeline, requiring adherence to strict standards and regulations. Coordinating numerous project partners and managing supply chain bottlenecks added to the complexity.

The solution

Working on a common goal as EPCMV partner

The huge planning effort under time pressure required a robust approach to project management, including effective communication, proactive risk management, flexible planning and stringent quality assurance. As a fast-track EPCMV professional, ZETA understands the levers for delivering complex CAPEX projects and impressed with a sound approach that met the extremely tight schedule. From the initial vision, a common goal was developed. As a trusted EPCMV partner, ZETA made the project a success.

End-to-end digitalization: benefits for engineering and operation

One key to dealing with enormous complexity lies in forward-looking digitalization strategies.

The deadline of just 25 months for the Loba biotech project was successfully met thanks to the use of FrameWORKS, a software platform with integrated digital Engineering Toolchain. The end-to-end digitalization of data enabled Loba biotech to use valuable smart tools, such as the MainMATE and VeriTIZE. Data from engineering is then leveraged in the operational business. Loba biotech especially benefits from simulation tools for process development and batch planning.

Mastered challenges.

Flexible, ergonomic, and safe working solutions

The ballroom concept for the downstream processing area allows a future multipurpose use of the production facility. The technical areas are characterized by optimal accessibility and maintainability.

Integrated digital testing to perform SAT

End-to-end digitization of data enabled Loba biotech to achieve paperless qualification. With ZETA’s support, the Site Acceptance Tests were conducted with VeriTIZE.

Technology transfer of production process

ZETA experts and TU Vienna partners jointly transferred and adapted the production process to state-of-the-art standards, redeveloping it entirely using a Quality by Design approach.
Production area with skids integrated in a platform on the left and scales on the floor, one loaded with a mobile container

Loba biotech

Gerhard Krejcy, Head of Manufacturing Science & Technology (MSAT)

“Loba biotech counts on digitalization in the production area. As a CDMO, or development partner, this results in enormous benefits for our start-up customers. The simulation of the manufacturing processes with real time data contributes greatly to the development of new active ingredients.”

Turn your vision into reality – start a project with us.

Johannes Koch
Director Business Line Engineering & Services
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