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- 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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