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Mammalian cell fermentation production 

A fully automated greenfield plant at the Debrecen site of Gedeon Richter, Hungary

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Gedeon Richter commissioned a fully automated, integrated and validated production, building management and environmental monitoring system for a multipurpose and flexible batch manufacturing greenfield facility dedicated to mammalian cell fermentation.

Expertise and experience for successful project execution

Richter selected ABB System 800xA technology and the engineering team, supported by international expertise and experience, to successfully deliver the project.

Gedeon Richter’s biotechnology production plant in Debrecen, Hungary is designed to produce mammalian cell fermentation based biopharmaceuticals. The plant will supply the international pharmaceutical market and complies to regulated market authority requirements. 

Gedeon Richter needed a partner that would provide the technology and engineering capability to deliver a complete automation solution for this multipurpose facility. 

The plant is designed for fully automated batch production with minimal operator intervention. Gedeon Richter required a technology providing a single platform for integrated batch manufacturing, building management and environmental monitoring system. Manufacturing efficiency is achieved through full operator visualization of all process and environmental information and data, complete batch reports and alarms and events audit trail. Engineering and maintenance efficiency is achieved through common hardware and software design for the entire plant.

Main facts

Industry   Pharmaceutical and life sciences
Customer   Gedeon Richter Plc
Country   Hungary
Solutions  

Process Automation System (PAS) with:

  • 800xA Control System with Batch Management
  • 27 Operator Workplaces
  • 5000 I/O signals

Building Management System (BMS) with:

  • 50 Air handling units
  • Utility and Energy Monitoring
  • 6200 I/O signals
Environmental Monitoring System (EMS)
  • 95 Room monitoring objects
  • Project management
  • Application engineering and testing
  • Installation and commissioning

Fully validated and integrated batch control, environmental monitoring and facility management system

Biotechnology requirements

The Process Automation System (PAS) has to comply with biotechnology requirements, like

  • Recipe-based Production Management (S88)
  • FDA 21 CFR Part 11 compliance
  • GAMP 5 based project execution complying with best practices in the life-science industries
  • All process control functions by a single DCS

Benefits for Gedeon Richter plc

Process Automation is an essential requirement for a modern biotechnology manufacturing facility. Microbiological and environmental safety is paramount and hence an effective Environmental Monitoring System (EMS) is key. Certain elements of the technology can only be enabled by an appropriate and all-encompassing Process Automation system, like the one ABB has delivered. The Process Automation System (PAS) allows for the necessary integration of technology steps and required remote control of the process technology. It drives effectiveness and efficiency,

The Process Automation System is a key element that makes the Gedeon Richter plc Debrecen biotechnology plant a "world class" facility.

Lajos Kovács, Technical Director of Gedeon Richter Plc
“ABB has global and local experience as well as reliable technology and well-proven engineering background both in pharmaceutical and petrochemical industries. These values have played a key role in the successful cooperation between Gedeon Richter Plc. and ABB over the last 16 year”
Fully automated batch control for upstream media preparation and fermentation and harvest

Fully automated batch control for downstream purification, buffer preparation and distribution

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