Driving CDMO Innovation with Integrated Automation Built on PlantPAx

In 2022, as demand for rapid infrastructure deployment increased during the COVID-19 pandemic, biopharmaceutical manufacturers faced the dual challenge of constructing production facilities in a short timeframe while achieving stable process operations with stronger reliability.

With the rapid growth of the biopharmaceutical market, global CDMOs are increasingly required to secure manufacturing capabilities that can meet stringent quality standards while enabling agile and responsive production. Given the direct impact of biopharmaceuticals on patient safety, regulatory authorities worldwide continue to strengthen their requirements for process reliability, data integrity, and full traceability.

To address these evolving industry demands, Prestige Biologics has been driving the development of a globally competitive CDMO production infrastructure, with a strong focus on biosimilars. In line with its ALITA Smart BioFactory strategy, the company is pursuing a manufacturing environment that balances flexibility and productivity through hybrid process operations.

This hybrid process model introduces significant complexity in process control and operations. At the same time, the need to shorten time-to-market while accommodating diverse production requirements across multiple clients highlighted the necessity for a more structured and standardized smart manufacturing environment.

Additionally, considering new facilities and plans for expanding multiple production sites, operating disparate, process-specific systems would increase management complexity and maintenance burdens.

In response, Prestige Biologics required a highly reliable automation solution capable of managing end-to-end biopharmaceutical manufacturing processes on a unified platform, delivering higher product quality and operational efficiency.

To address these challenges, Prestige Biologics adopted Rockwell Automation’s PlantPAx® distributed  control system (DCS) -based integrated automation and information solution to enhance process stability, operational efficiency, and digital quality management capabilities.

Through the PlantPAx® integrated platform, core functions—process control, batch management, data management, and asset management—have been unified within a standardized environment. By connecting OT and IT systems, the company established a data-driven operating model that enhances real-time visibility across the entire production process. This also enabled the implementation of electronic records and management systems based on data integrity, significantly strengthening regulatory compliance capabilities.

In addition, by leveraging modular process design and a standardized engineering environment, Prestige Biologics developed an operational framework capable of flexibly responding to diverse product types and changing production conditions. A scalable automation architecture was also established to support future expansion across multiple production sites.