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Volume 1
Issue 2 JULY– DECEMBER 2025
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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Issue 1 JANUARY- JUNE 2025
Volume 1(Issue 1) JANUARY- JUNE 2025 Research Articles
A Quality by Design (QbD) technique has been used to build a robust HPLC method for measuring pegfilgrastim
Vol.1(1); Pages:1-9. Published on April-2025
Abstract
A new reversed-phase HPLC method for estimating Pegfilgrastim was validated by using a Quality by Design (QbD) approach. Careful risk evaluation showed that mobile phase composition, rate of flow through the system and the detection wavelength were the most significant variables and these were improved by using experimental approaches. The finalized method proved to be specific, precise, accurate, linear and robust, all in line with International Council for Harmonisation (ICH) guidelines. Specificity was shown by the clear division of Pegfilgrastim from any other materials and those that had degraded. Repeated tests indicated that precision was good, since accuracy was showed by the recovery of known levels within an expected range. The results were very linear through a concentration range used in treatment and repeated testing did not affect the method’s performance. Because of QbD, the approach helps researchers understand how to control important aspects for consistent and trustworthy results. Routine quality control and stability testing of Pegfilgrastim drugs are easily carried out using the approved HPLC technique.
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Driving Forces Shaping the Future of Pharmacy Education: Academic, Social, Technological, Economic, and Political Perspectives
Vol.1(1); Pages:10-16. Published on April-2025
Abstract
Pharmacy education is at a pivotal moment, shaped by intertwined academic, social, technological, economic, and political forces, collectively known as ASTEP. The COVID-19 pandemic acted as a catalyst, accelerating the need to rethink and innovate traditional educational models. This paper explores these driving forces and their impact on pharmacy education, highlighting opportunities for transformative change. Emphasizing competency-based learning, digital integration, and equitable access, it advocates for disruptive innovation to better prepare pharmacy professionals for evolving healthcare demands. By examining the challenges and possibilities within each ASTEP domain, this work provides a strategic framework for educators and policymakers aiming to future-proof pharmacy education in a post-pandemic era.
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Making recombinant Erythropoietin in large quantities using CHO cells in a fed-batch bioreactor
Vol.1(1); Pages:28-38. Published on April-2025
Abstract
This study describes how to improve and produce more of rhEPO in a reactor that uses CHO cells. A thorough Design of Experiments (DoE) was used to find the best settings for key elements like feeding strategy, dissolved oxygen and pH, to increase cell growth and protein production. Steps for optimized production were tested in a 50L scale and led to a 2.8-fold rise in yield compared to ordinary batch cultures. Experiments using SDS-PAGE and HPLC showed that the substance was pure and well structured and bioactivity was also confirmed in our in-vitro assays. According to these findings, an industrial-scale rhEPO process can be made scalable, strong and regulation. Analysis downstream was performed to check the quality and integrity of the manufactured rhEPO. The protein sample was shown to be very pure and structurally accurate by performing SDS-PAGE and HPLC. Additionally, experiments in the laboratory (in-vitro) indicated that rhEPO had strong biological activity which makes it a possible treatment. It is shown in this study that by following a proper optimization technique, the production of rhEPO in CHO cells can be greatly increased. The process can be used on a large scale, it works well and meets the requirements set by regulations, so rhEPO can be manufactured in the biopharmaceutical industry on a large scale.
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Process Optimization and Quality Assessment of Recombinant Human Insulin Using Continuous Bioprocessing
Vol.1(1); Pages:39-48. Published on April-2025
Abstract
The transition to continuous bioprocessing represents a transformative advancement in the production of recombinant therapeutics, offering enhanced efficiency and cost-effectiveness. This study presents the development and optimization of a continuous bioprocess for recombinant human insulin utilizing perfusion bioreactor systems. Through a Design of Experiments (DoE) approach, critical process parameters (CPPs) and critical quality attributes (CQAs) were systematically identified and optimized to ensure process robustness and product consistency. Comprehensive analytical techniques, including high-performance liquid chromatography (HPLC), SDS-PAGE, and mass spectrometry, were employed for in-depth characterization of insulin quality. The optimized continuous process demonstrated significant improvements in yield, purity, and scalability while adhering to stringent regulatory requirements. These results highlight the potential for continuous manufacturing to revolutionize insulin production and suggest its applicability to a broader range of biopharmaceuticals, encouraging industry-wide adoption of more sustainable and efficient production models.
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