Next Generation Manufacturing Of Biologics: How Digital Innovation And Sustainability Are Redefining Biomanufacturing

By Dr. Harald Bradl, Director Downstream Development, and Dr. Fabian Vogt, Head of Laboratory Downstream

Biologics manufacturing is undergoing a transformation: Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.

A key element is scale-oriented development – from early process design to production in 12,000-liter bioreactors. Tools like Computational Fluid Dynamics and digital twins enable precise characterization and optimization of equipment and processes.

High-throughput screening accelerates development and improves predictability of process outcomes. Mechanistic and holistic process modeling both provide a comprehensive, data-driven foundation for quality control and process optimization.

Sustainability is integral: energy-efficient operations, water reduction and digital tools promote both environmental responsibility and operational excellence.