Towards smart biomanufacturing: a perspective on recent developments in industrial measurement and monitoring technologi
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BIOTECHNOLOGY METHODS - ORIGINAL PAPER
Towards smart biomanufacturing: a perspective on recent developments in industrial measurement and monitoring technologies for bio‑based production processes Carina L. Gargalo1 · Isuru Udugama1 · Katrin Pontius1 · Pau C. Lopez1 · Rasmus F. Nielsen1 · Aliyeh Hasanzadeh1 · Seyed Soheil Mansouri1 · Christoph Bayer2 · Helena Junicke1 · Krist V. Gernaey1 Received: 22 June 2020 / Accepted: 31 August 2020 © The Author(s) 2020
Abstract The biomanufacturing industry has now the opportunity to upgrade its production processes to be in harmony with the latest industrial revolution. Technology creates capabilities that enable smart manufacturing while still complying with unfolding regulations. However, many biomanufacturing companies, especially in the biopharma sector, still have a long way to go to fully benefit from smart manufacturing as they first need to transition their current operations to an information-driven future. One of the most significant obstacles towards the implementation of smart biomanufacturing is the collection of large sets of relevant data. Therefore, in this work, we both summarize the advances that have been made to date with regards to the monitoring and control of bioprocesses, and highlight some of the key technologies that have the potential to contribute to gathering big data. Empowering the current biomanufacturing industry to transition to Industry 4.0 operations allows for improved productivity through information-driven automation, not only by developing infrastructure, but also by introducing more advanced monitoring and control strategies. Keywords Bioprocesses · Industry 4.0 · Big data · Control · Sensors · Smart biomanufacturing Abbreviations AI Artificial intelligence BCA Background corrected absorption NAD(P)H Nicotinamide adenine dinucleotide phosphate FDA Food and drug administration FTIR Fourier-transform infrared spectroscopy GC–MS Gas chromatography–Mass spectrometry GFP Green fluorescent protein GMP Good manufacturing practice HMI Human machine interfaces HPLC High-performance liquid chromatography MIR Mid-infrared spectroscopy ML Machine learning MVDA Multivariate data analysis * Krist V. Gernaey [email protected] 1
Process and Systems Engineering Center (PROSYS), Department of Chemical and Biochemical Engineering, Technical University of Denmark, Kgs. Lyngby, Denmark
Department of Process Engineering, TH Nuremberg, Nuremberg , Germany
2
NIR Near infrared OD Optical density PAT Process analytical technologies PCA Principal components analysis PCC Pearson correlation coefficient PLS Partial least squares QbD Quality by design TA Total absorption TRL Technology readiness level UV Ultraviolet YFP Yellow fluorescent protein YPD Yeast extract peptone dextrose
Introduction Industry 4.0 and the smart manufacturing movement now provide biomanufacturing the opportunity to upgrade its production processes to be in harmony with the latest industrial revolution [118]. Due to the promise of increased productivity a
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