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- Volume 1(Issue 1) JANUARY- JUNE 2025
Research Articles
Fed-batch fermentation using E. coli is an efficient way to optimally make recombinant human growth hormone (rhGH)
Vol.1(1); Pages:1-8. Published on May-2025
Abstract
The Early Warning Score (EWS) is very useful in identifying the early signs of clinical deterioration for patients in critical care, so that appropriate care is provided early. The authors test whether a Rapid Response Training program improves nurses’ EWS procedures and greatly impacts how patients are cared for. Involved were 72 nurses in basic training over two weeks which consisted of scenario-based exercises and clinical observation. Patient data that included how fast cases were handled, the accuracy of escalations and the status of the case post-escalation were studied both before and after the training. Researchers found that RRT considerably improved how fast nurses acted on warning signs and sent patients to the ICU as needed. The discovery highlights the use of organized and planned training to strengthen rapid response teams, ensure patient safety in critical care and help teams respond promptly to patients’ needs.
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Stability-indicating RP-HPLC method is developed to determine the amount of trastuzumab in lyophilized formulations
Vol.1(1); Pages:9-15. Published on May-2025
Abstract
The presence of HER2 in breast cancer means that the antibody trastuzumab needs special careful analysis since it can break down easily. A stability-indicating RP-HPLC technique was created and validated in this study for determining the concentration of trastuzumab from lyophilized formulations. The C18 column, gradient elution and detection at 280 nm using UV light were used to find the best chromatographic conditions. All of these experiments, involving temperature, oxygen and acid, proved that the method is highly specific. The process of validation was based on ICH Q2(R1) guidelines and checked for linearity, accuracy, precision and robustness. It was found that this method enabled proper evaluation of trastuzumab for commercial and pilotscale purposes, ensuring all regulations were properly met and quality was maintained during its production.
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The creation and understanding of liposomal doxorubicin targeted at tumors with less heart damage
Vol.1(1); Pages:16-24. Published on May-2025
Abstract
Doxorubicin is a useful medicine for chemotherapy, but its use in patients is restricted by the risk of cardiac problems. The purpose of this study is to create a liposomal form of doxorubicin to achieve better tumor targeting and lower the drug’s harmful effects on the body. Thin-film hydration was used to form liposomes and then the liquid was extruded and doxorubicin was loaded remotely. Characterization methods were used to check particle size, zeta potential, percentage of drug load and drug discharge in laboratory experiments. According to the results, the optimized formulation had a particle size of 112 nm, a high encapsulation efficiency of more than 90% and a sustained period of drug release lasting 48 hours. The same amount of effectiveness was observed in cytotoxicity testing using MCF-7 cells and the drug molecule proved to be much less toxic to H9c2 cells. From the findings, liposomal doxorubicin is considered safer than traditional cancer drugs and encourages further testing in living organisms.
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An Examination of How Single-Use Bioreactors and Traditional Stainless Steel Systems Compare in Making mAb by Looking at Production and Total Expenses
Vol.1(1); Pages:25-33. Published on May-2025
Abstract
With more demand for mAbs, people are interested in flexible and budget-friendly ways to produce them. This work examines and compares single-use bioreactor systems to regular stainless steel bioreactors when producing mAbs with CHO cells at pilot scale. Things we assessed were productivity, the cost involved, risks of contamination and how much time the plant could be down for cleaning. Conclusions showed that though stainless steel produced more antibody, SUBs cut cleaning validation time, lowered operational difficulty and lowered the chance of cross-contamination. With SUBs, the costs in each area were reduced by 22%. It has been found that single-use systems represent scalable and reliable alternatives in today’s biopharmaceutical production, since they are flexible, cost-effective and need little upkeep. It was suggested that although stainless steel bioreactors have an edge in productivity, SUBs appear to be suitable for handling the economic and logistical difficulties that occur with the production of mAbs. Greater use of SUBs in manufacturing conditions should be investigated further to understand their long-term results for mAb manufacturing.
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Use of Quality Risk Management (QRM) in the Production of Aseptic Biopharmaceuticals through a Case Study
Vol.1(1); Pages:34-42. Published on May-2025
Abstract
Making biopharmaceuticals by aseptic methods is vital, though these processes are at risk of both contamination and problems in operation. This paper looks at how Quality Risk Management (QRM) practices are applied in an aseptic filling line in the industrial setting. Using ICH Q9 as a reference, risk assessment was carried out that included process mapping, failure mode and effects analysis and strategies for controlling risks to locate any potential issues. The main concerns found were mistakes in intervening in critical moments, missing important checks of the area and problems with equipment cleaning. Changing the Standard Operating Procedures, retraining the staff and continuous observation lowered the number of contamination and deviation instances. The author points out that using QRM helps improve product sterility and meet all the rules in places where biopharmaceuticals are made. Implementing these principles allows manufacturers to reduce the risk and increase the dependable safety of producing biologics.
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