This project consists in preparing for the commercial launch of a bioproduction facility dedicated to BIMEKIZUMAB, with a capacity of 3 × 10,000 liters, integrating advanced automation and a multi-product expansion strategy, while committed to carbon neutrality.
2018 - 2025
Belgium
Health and life science
Faced with the rise of biological products, the new INFLEXIO bioproduction facility is positioning itself as a major player by completely rethinking its manufacturing process. The project includes the preparation for the commercial launch of the first monoclonal antibody BIMEKIZUMAB at UCB Braine, with a production capacity of 3 × 10,000 liters.
To meet future needs, the extension provides multi-product flexibility and advanced process automation, integrating single-use technologies and an MES system controlling electronic records for the upstream phase. In addition, the installation connects on a robust infrastructure — PCS7 and WinCC for the control of CIP, SIP and bioreactor operations — and provides strategies for optimizing resources (water, energy, waste management). A mentoring program and a gradual ramp-up support this transformation, with particular attention paid to quality compliance and a sustainable commitment to carbon neutrality.
The customer wants to create a bioproduction facility at the cutting edge of innovation, capable of accommodating several organic products while guaranteeing automated production and optimal quality management. He provides a global solution that integrates technology transfer, process automation, adapted EHS management and long-term operational flexibility. The challenge is to support commercial launch by reducing deadlines, increasing production capacity and ensuring a sustainable commitment to carbon neutrality.
Design a flexible and automated installation for bioproduction.
Ensure scale-up and qualification through hybrid systems.
Guarantee a sustainable commitment and optimal quality management.
The mission is to orchestrate the technical and operational preparation of the INFLEXIO installation, from technology transfer to PPQ qualification. It involves implementing hybrid automation tools to simultaneously manage electronic and paper records, and coordinating EHS and quality control strategies. The objective is to guarantee an efficient ramp-up in line with commercial requirements while ensuring continuous control of production processes.
Transfer the technology and achieve the PPQ qualification for the new installation.
Integrate hybrid automation systems for batch management.
Ensure control of operations with a dedicated mentoring program.
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