Welcome to the repository of current of IJIBPQ. This section provides access to all published content, allowing readers to explore the latest advancements and archived contributions in the field of biopharmaceutical manufacturing and quality research.
Featured Articles in the Latest Issue
- Volume 1 (Issue 2) JULY– DECEMBER 2025
Research Articles
Implementation of Real-Time Release Testing in Continuous mRNA Vaccine Drug-Substance Production: Pilot Scale Demonstration
Vol.1(2); Pages:1-10. Published on July-2025
Abstract
The potential benefits of continuous manufacturing (CM) of mRNA drug-substance are listed as reduced lead time and enhanced product consistency. Nevertheless, to realize CM on a large scale in mRNA vaccine manufacturing, the effective in-line quality control mechanisms need to be incorporated. The current pilotscale study shows the combination of continuous flow-through in-vitro transcription (IVT) reactors with realtime release testing (RTRT) tools to facilitate on-line assessment of critical quality attributes (CQAs). With a mRNA construct of the prefusion-stabilized SARS-CoV-2 spike protein, the yield was 30 g L -1 day -1. immediate quantification and integrity profiling was performed by UV/Vis spectroscopy and fluorescence-based capillary electrophoresis, whereas purity could be confirmed by rapid HPLC-RNase mapping within 20 minutes. The experiment observed a less than 4 percent relative standard deviation of mRNA yield within 48 hours of run time and 98 percent agreement between RTRT data and traditional off-line assays. A residencetime distribution model and feedback control made it possible to control the pH (< 7.4) and NTP conversion (> 92%), previously manual and batch-wise adjustments were necessary. The standalone CM-RTRT system cut the total release time by more than 48 hours to less than 4 hours, and the data trajectories were according to ICH Q13 recommendations.
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Quality by Design-Based Optimization of Recombinant Protein Purification for Improved Process Robustness
Vol.1(2); Pages:11-21. Published on October-2025
Abstract
The incorporation of Quality by Design (QbD) principles in the biopharmaceutical manufacturing has transformed the optimization of the process. In this paper, a QbD framework was used to optimize the process of purifying a re-engineered therapeutic protein that was produced in CHO cells. A design of experiments (DoE) approach was used to systematically vary critical process parameters, including resin type, flow rates and buffer composition. Statistical modeling determined the best operating conditions that reduced loss of product and co-eluting impurities. An increase of 26 percent in yield and a decrease of 40 percent in host cell protein content relative to baseline conditions were the outcomes of the optimized process. Moreover, robustness testing of the simulated process variability was consistent. This paper emphasizes the importance of QbD in enhancement of product quality, process robustness and regulatory compliance biopharmaceutical purification.
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Comparative Study of Continuous Versus Hybrid Manufacturing Approaches in Biopharmaceutical Production
Vol.1(2); Pages:22-32. Published on November-2025
Abstract
The transition to the production of biopharmaceuticals on a continuous basis has been introduced as the answer to the increased efficiency, flexibility, and cost-effectiveness. Hybrid systems involving continuous and batch operations are however becoming an option of interest. This paper discusses the comparison of continuous and hybrid production process in the manufacture of a monoclonal antibody on a pilot scale, the main metrics used as the throughput of the process, utilization of the facility, quality of the product and the cost of the operational process. Continuous production proved to be better in throughput and facility footprint and hybrid systems provided greater multiproduct facility adaptability. Both methods were compliant with regulatory critical quality attribute. According to cost modeling, hybrid systems are proposed to be a good intermediary step that facilities that have not yet fully implemented continuous processes can use. The findings provide manufacturers with information on how to trade off innovation and regulatory demands with economic aspects.
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Digital Twins in Biopharmaceutical Manufacturing: A Predictive Tool to Advance the Control of the Process
Vol.1(2); Pages:33-39. Published on November-2025
Abstract
Digital Twin technology for biopharmaceutical manufacturing is transformative for predictive process monitoring and control. This study describes the development of a digital twin of a fed-batch mammalian cell culture system, using mechanistically-based models together with machine learning algorithms trained using historical datasets from the production. The predictive performance of the model was verified in five pilot-scale runs with mean absolute error of less than 7% for the key parameters of viable cell density and product titer. Importantly, the digital twin was able to identify early deviations in the glucose uptake and enabled early interventions to avoid batch failures. These results show that digital twins can improve process ruggedness, aid in regulatory compliance and accelerate innovation, and provide an important tool for modern Industry 4.0- enabled biopharmaceutical manufacturing.
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Regulatory Insights into Advanced Analytical Techniques for Biopharmaceutical Quality Assurance
Vol.1(2); Pages:40-47. Published on December-2025
Abstract
The last few years have seen a dramatic improvement in analytical technologies for quality assurance in biopharmaceutical production. This paper examines regulatory views on the use of next-generation analytical platforms, such as multi-attribute methods (MAMs), capillary electrophoresis, and high resolution mass spectrometry, for characterising critical quality attributes (CQAs). A recent regulatory filings survey of North America and Europe examined acceptance trends and implementation issues. Case studies showed that detection of microheterogeneity was improved and the dependence on multiple orthogonal methods was reduced by advanced analytics. Validation experiments proved robustness, reproducibility and International Council for Harmonisation (ICH) compliance. Regulatory agencies are conducive to innovation; however, unambiguous comparability methodology is still a fundamental criterion for licensure applications. These results provide a structure for incorporating new analytical technology into biopharmaceutical QA in a manner consistent with regulatory alignment.
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