Lecture
Advancing Bioprocess Analytics with Spectroscopy – From Proven Standards to Custom Concepts
- at -
- A3.527
- Type: Lecture
Lecture description
Bioprocesses are becoming increasingly complex and diverse as modern biopharmaceutical development expands beyond classical recombinant protein production. Emerging cell and gene therapy approaches, for example, involve highly sensitive living systems with fundamentally different requirements regarding nutrient supply, metabolic control, and process dynamics. In parallel, established bioprocesses are continuously optimized to increase yields, ensure consistent product quality, and reduce manufacturing costs while complying with strict regulatory frameworks such as GMP and process-specific guidelines. UV/Vis, NIR and Raman spectroscopic measurements, performed in-line, at-line, on-line, or off-line, provide valuable insight into critical process parameters and support Process Analytical Technology (PAT) and Quality by Design (QbD) strategies, with real-time capabilities for in-line, at-line, and on-line implementations. By enabling non-invasive, continuous measurements, spectroscopy improves process understanding, reduces variability, and supports robust and cost-efficient biomanufacturing. Reliable spectroscopic analytics depend on robust optical materials and components. Proven glass and quartz elements, including cuvettes, flow cells, and probe interfaces, form the foundation of many analytical systems. However, as bioprocesses become more diverse, standardized optical designs are often no longer sufficient. Different process types, regulatory requirements, and manufacturing concepts, particularly the increasing adoption of single-use systems, demand application-specific optical solutions that meet both performance and compliance expectations. At the same time, economic constraints require such components to be produced in a scalable and cost-efficient manner. This presentation demonstrates how application-specific, quartz-based spectroscopic components can be realized using a novel quartz cold-casting (QCC) technique. This approach enables the cost-efficient and highly precise production of customized quartz cells that integrate seamlessly into GMP-compliant, single-use process environments. The concept is showcased using a specific spectroscopic product, illustrating how tailored optical design enhances the robustness and reliability of process analytics. Improved measurement performance leads to deeper process and product understanding, ultimately reducing development time, operational risk, and overall manufacturing cost. By strengthening the link between application-specific hardware design and spectroscopic analytics, this work highlights how advanced optical components support QbD-driven process development and robust manufacturing, contributing to the advancement of next-generation bioprocesses and therapies.
