ArticleAnalytical and bioanalytical chemistry2020
Multi-attribute PAT for UF/DF of Proteins-Monitoring Concentration, particle sizes, and Buffer Exchange.
Article in Analytical and bioanalytical chemistry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- A Novel Raman-Chromatography Assembly for Automated Calibration and In-Line Monitoring in Bioprocessing.Engineering in life sciences · 2025Article
- Current PAT Landscape in the Downstream Processing of Biopharmaceuticals.Analytical science advances · 2025Review
- Raman-based PAT for multi-attribute monitoring during VLP recovery by dual-stage CFF: attribute-specific spectral preprocessing for model transfer.Frontiers in bioengineering and biotechnology · 2025Article
- Spectroscopic insights into multi-phase protein crystallization in complex lysate using Raman spectroscopy and a particle-free bypass.Frontiers in bioengineering and biotechnology · 2024Article
- Monitoring of ultra- and diafiltration processes by Kalman-filtered Raman measurements.Analytical and bioanalytical chemistry · 2023Article
- In-line monitoring of protein concentration with MIR spectroscopy during UFDF.Engineering in life sciences · 2023Article
- Continuous background correction of refractive index signal to improve monoclonal antibody concentration monitoring during UF/DF and SPTFF operations.Bioprocess and biosystems engineering · 2022Article
- Application of inline variable pathlength technology for rapid determination of dynamic binding capacity in downstream process development of biopharmaceuticals.Biotechnology progress · 2022Article
- Process Analytical Technologies and Data Analytics for the Manufacture of Monoclonal Antibodies.Trends in biotechnology · 2020Review
- A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing.Analytical and bioanalytical chemistry · 2020Review
- Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Ultrafiltration/diafiltration (UF/DF) plays an important role in the manufacturing of biopharmaceuticals. Monitoring critical process parameters and quality attributes by process analytical technology (PAT) during those steps can facilitate process development and assure consistent quality in production processes. In this study, a lab-scale cross-flow filtration (CFF) device was equipped with a variable pathlength (VP) ultraviolet and visible (UV/Vis) spectrometer, a light scattering photometer, and a liquid density sensor (microLDS). Based on the measured signals, the protein concentration, buffer exchange, apparent molecular weight, and hydrodynamic radius were monitored. The setup was tested in three case studies. First, lysozyme was used in an UF/DF run to show the comparability of on-line and off-line measurements. The corresponding correlation coefficients exceeded 0.97. Next, urea-induced changes in protein size of glucose oxidase (GOx) were monitored during two DF steps. Here, correlation coefficients were ≥ 0.92 for static light scattering (SLS) and dynamic light scattering (DLS). The correlation coefficient for the protein concentration was 0.82, possibly due to time-dependent protein precipitation. Finally, a case study was conducted with a monoclonal antibody (mAb) to show the full potential of this setup. Again, off-line and on-line measurements were in good agreement with all correlation coefficients exceeding 0.92. The protein concentration could be monitored in-line in a large range from 3 to 120 g L
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