Realization of user‐friendly bioanalytical tools to quantify and monitor critical components in bio‐industrial processes through conceptual design

Abstract

This minireview suggests a conceptual and user-oriented approach for the design of process monitoring systems in bioprocessing. Advancement of process analytical techniques for quantification of critical analytes can take advantage of basic conceptual process design to support reasoning, reconsidering and ranking solutions. Issues on analysis in complex bio-industrial media, sensitivity and selectivity are highlighted from users' perspectives. Meeting challenging analytical demands for understanding the critical interplay between the emerging bioprocesses, their biomolecular complexity and the needs for user-friendly analytical tools are discussed. By that, a thorough design approach is suggested based on a holistic design thinking in the quest for better analytical opportunities to solve established and emerging analytical needs. K E Y W O R D Sbioanalytics, conceptual design, critical process parameters, critical quality attributes, process analytical technology (PAT) THE DESIGNER PERSPECTIVE ON BIOPROCESS ANALYTICSTo acquire relevant information useful for achieving product quality from industrial biotechnology production systems is still a challenge to engineering design although the fundamentals are well known since long [1]. This need is distinctly expressed and motivated by organizations as the

The Rapid Determination of Three Toxic Ginkgolic Acids in the Decolorized Process of Ginkgo Ketone Ester Based on Raman Spectroscopy and ResNeXt50 Deep Neural Network

“…In 2002, the U.S. Food and Drug Administration (FDA) introduced Process Analytical Technology (PAT) as an innovative approach aimed at enhancing process efficiency and control. PAT involves monitoring critical process parameters either in situ, online, bypass, or offline, ensuring they consistently fall within specified ranges to uphold the final product's quality [6,7]. This methodology has gained widespread acceptance in the quality control of traditional Chinese medicine production processes.…”