Article
Biochemical Research Methods
Juliane Diehm, Lennart Witting, Frank Kirschhoefer, Gerald Brenner-Weiss, Matthias Franzreb
Summary: Continuous manufacturing is increasingly important in the (bio-)pharmaceutical industry, and there is a need for powerful continuous analytical tools. This study demonstrates the feasibility of using a micro simulated moving bed chromatography system for continuous on-line sample preparation for mass spectrometry. The integration of this system significantly increases mass spectrometry sensitivity and provides a versatile tool for quality assessment in biopharmaceutical processes.
ANALYTICAL AND BIOANALYTICAL CHEMISTRY
(2023)
Review
Engineering, Chemical
Yu Kiat Lin, Hui Yi Leong, Tau Chuan Ling, Dong-Qiang Lin, Shan-Jing Yao
Summary: Downstream processing or product recovery is crucial in bioprocess development, with continuous manufacturing making Process Analytical Technologies (PATs) essential. Spectroscopic methods, particularly Raman spectroscopy, are widely used for real-time monitoring of analytes with minimal sample processing. The innovation of enhanced Raman spectroscopy coupled with chemometrics provides a reliable alternative for downstream process analysis.
CHINESE JOURNAL OF CHEMICAL ENGINEERING
(2021)
Review
Chemistry, Analytical
Daniel Schorn-Garcia, Julieta Cavaglia, Barbara Giussani, Olga Busto, Laura Acena, Montserrat Mestres, Ricard Boque
Summary: This article guides readers on monitoring fermentation using ATR-MIR spectroscopy and chemometric techniques, emphasizing the importance of sampling for modeling, providing methods for setting parameter for good signal quality, and explaining data preparation and calculations. The modeling strategies utilizing basic chemometric tools are effective and affordable for both experts and non-experts.
MICROCHEMICAL JOURNAL
(2021)
Article
Materials Science, Multidisciplinary
Manya Mittal, Surbhi Gupta, Anurag S. Rathore
Summary: This paper proposes a method for real-time monitoring of atomic layer deposition (ALD) coating on an active pharmaceutical ingredient (API) using Raman spectroscopy, with Palbociclib as the model drug. By measuring product quality attributes such as homogeneity, surface modifications, and dissolution profile, and developing a principal least squares (PLS) model, the proposed approach accurately monitors the ALD coating online.
MATERIALS CHEMISTRY AND PHYSICS
(2022)
Article
Biochemical Research Methods
Laura Rolinger, Juergen Hubbuch, Matthias Ruedt
Summary: Monitoring the protein concentration and buffer composition during UF/DF step is crucial for biopharmaceutical production automation and real-time release testing. This study demonstrates the advantages of combining Raman spectroscopy with EKF for monitoring the UF/DF step, showing improved sensitivity and faster measurement speed.
ANALYTICAL AND BIOANALYTICAL CHEMISTRY
(2023)
Article
Chemistry, Analytical
Alexander Graf, Angus Woodhams, Michael Nelson, Douglas D. Richardson, Steven M. Short, Mark Brower, Marek Hoehse
Summary: This research presents a novel approach to generating reliable Raman models using a high-throughput mini bioreactor system, allowing for real-time monitoring and control of biologics manufacturing.
Article
Energy & Fuels
Jun Xu, Xingrui Xiang, Kai Xu, Limo He, Hengda Han, Sheng Su, Yi Wang, Song Hu, Jun Xiang
Summary: This study utilized microRaman spectroscopy to investigate the chemical structures of coal at a micro-scale, revealing significant heterogeneity in the micro-scale. The evolution of char particles in micro-scale differs from each other, especially in the early stage of pyrolysis, but tends to converge as the process progresses. The results suggest that a more severe pyrolysis condition can lead to a char with higher heterogeneity, and the pyrolysis of Zhundong coal can be mainly divided into two stages in terms of bulk structural evolution.
Article
Food Science & Technology
Ana Borba, Andrea Gomez-Zavaglia
Summary: Infrared spectroscopy is a powerful yet underutilized technique in the field of Food Science and Technology. This review highlights the available approaches for analyzing the physical and chemical properties of food products and ingredients using infrared spectroscopy, including macromolecules and changes resulting from processing and storage. The use of infrared spectroscopy should be encouraged for rapid and accurate determinations in both academic and industrial contexts.
CURRENT OPINION IN FOOD SCIENCE
(2023)
Article
Biotechnology & Applied Microbiology
Vishwanath Hebbi, Garima Thakur, Anurag S. Rathore
Summary: This study utilized a combined spectroscopic and statistical approach to monitor and control the PEGylation reaction for G-CSF using near infrared spectroscopy (NIRS). The online NIRS probe tracked the conversion of G-CSF into different PEGylated forms in real time, while the spectra were used to build a batch evolution model and detect deviations. The system successfully identified and corrected four common deviations in the PEGylation process, demonstrating the potential for quality by design framework in biotechnology manufacturing.
JOURNAL OF BIOTECHNOLOGY
(2021)
Article
Food Science & Technology
Silvia Grassi, Lorenzo Strani, Cristina Alamprese, Nicolo Pricca, Ernestina Casiraghi, Giovanni Cabassi
Summary: This study proposes a process analytical technology approach using near infrared spectroscopy and multivariate statistical process control charts for the control of milk coagulation. The results demonstrate the effectiveness of this method in monitoring coagulation times and detecting possible failures.
Article
Engineering, Chemical
Lara Julia Lohmann, Jochen Strube
Summary: The research demonstrated the feasibility of online measurement techniques such as Raman spectroscopy within the framework of process analytical technology. By combining DAD and Raman, higher process robustness and accuracy were achieved.
Article
Chemistry, Physical
Martina Alunni Cardinali, Assunta Morresi, Daniele Fioretto, Leonardo Vivarelli, Dante Dallari, Marco Govoni
Summary: This study explores the potential of using Brillouin and Raman micro-spectroscopic (BRmS) technique for studying bone tissue, demonstrating its capability in discovering morpho-mechanics of bone cells, extracellular matrix, and marrow constituents. The results reveal specific alterations in morphology and tissue chemical composition in different anatomical regions, which significantly affect bone mechanical properties and provide a potentially extendable method for other important biomedical issues.
Article
Biotechnology & Applied Microbiology
Christopher Gillespie, Dhanuka P. Wasalathanthri, Diana B. Ritz, George Zhou, Keith A. Davis, Thomas Wucherpfennig, Nadine Hazelwood
Summary: The study evaluated the business value of PAT technologies in biotherapeutic development, highlighting the different values various PAT tools hold in upstream and downstream processes. The results aim to assist current practitioners and newcomers in prioritizing and steering their projects towards success.
BIOTECHNOLOGY AND BIOENGINEERING
(2022)
Article
Chemistry, Analytical
Gabriella Gerzon, Yi Sheng, Marina Kirkitadze
Summary: Process Analytical Technology (PAT) instruments optimize process controls by measuring parameters and attributes in real time, mainly applied in pharmaceutical manufacturing. PAT solutions aim to achieve quality control and real-time product release, promoting production efficiency and reducing production costs.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2022)
Article
Pharmacology & Pharmacy
Raul S. Rangel-Gil, Nobel O. Sierra-Vega, Rodolfo J. Romanach, Rafael Mendez
Summary: This study presents the implementation of Raman spectrometer in a stream sampler for real-time monitoring of low drug concentration. Raman spectra were continuously acquired as powder blends flowed through the sampler operating at a paddle wheel speed of 10 RPM and used to develop a calibration model. The calibration model based on Partial Least Squares Regression (PLS-R) accurately quantified caffeine concentration in the range of 1.50% to 4.50% w/w. Evaluation of the model using test blends showed a root mean square error of prediction of 0.21% w/w and a low bias of -0.03% w/w. Variographic analysis demonstrated low process variance of real-time spectral acquisition. The results highlight the capability of the Raman spectrometer coupled with the stream sampler for monitoring low drug concentration in poor flowability blends.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
