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Volume 1
Issue 2 JULY– DECEMBER 2025
Volume 1 (Issue 2) JULY– DECEMBER 2025 Research Articles
Comparative Stability Analysis and Process validation of Biosimilar Bevacizumab produced in Two facilities
Vol.1(2); Pages:1-9. Published on July-2025
Abstract
It is imperative that similar results be produced by different facilities in the name of consistency in an attempt to maintain therapeutic equivalence as well as assure regulatory conformity. This work aim was to compare process validation and product stability of biosimilar bevacizumab manufactured in two independent GMPcompliant biopharmaceutical facilities. The observations were made on the monitoring of key critical process parameters (CPPs) and critical quality attributes (CQAs) of manufacturing three consecutive commercial-scale batches at each site. Size-exclusion chromatography-high-performance liquid chromatographic (SEC-HPLC), capillary isoelectric focusing (cIEF), glycan profiling, and bioassays were used to determine the analytical comparability. Both accelerated and long term stability studies were done in relation to ICH guidelines. The trial outcomes demonstrated the modest intensity of the inter-site variation and all the parameters investigated were within the acceptable limits. The stability profiles of the biosimilars were quite comparable which had implicated the potency of the product between the production sites. Such data form the basis of global scale-up intentions and regulatory submission paths of biosimilars produced in greater than one facility, and hence their proven therapeutic equivalence and time stability across markets.
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Advanced Perfusion Bioreactor Approaches for Large-Scale Monoclonal Antibody Manufacturing in CHO Cells
Vol.1(2); Pages:10-19. Published on October-2025
Abstract
Monoclonal antibodies (mAbs) are valuable therapeutic proteins, in need of scalable and robust production systems. Intensified perfusion bioreactor approaches to Chinese hamster ovary (CHO) cell cultures are assessed using high-density plug and media exchange, along with nutrient monitoring in real-time. Perfusion cultures demonstrated a 3.1-fold higher volumetric productivity as compared to conventional fed-batch processes, and showed equal product quality in glycosylation profiles and aggregation levels. Automatic correction of perfusion rates with the use of online biomass sensors enabled to minimize media consumption by 18%. These findings demonstrate the possible economic applicability of perfusion-based intensification to enhance the economics and quality of mAb production with potential implications to heavy-load commercial antibody production.
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Ongoing development of recombinant erythropoietin via an integrated system of chromatography
Vol.1(2); Pages:20-30. Published on November-2025
Abstract
Bioprocessing is one of the essential ways of transforming batch to continuous processing, which is a critical step in enhancing the efficiency and scalability of the biologics manufacturing process. This paper presents an in-line comprehensive purification technique to recombinant human erythropoietin (rhEPO) applying a multicolumn chromatography setup to process the protein continuously without interruption in process, polishing, and screening of viruses. Continuous processing exhibited higher resin usage (42 percent), less buffer usage (29 percent) and a shorter overall process (37 percent) compared with a traditional batch process. Characterization of the product in terms of its bioactivity and glycosylation pattern by mass spectrometry demonstrated identical product characteristics to those of reference standards. These results indicate that continuous process of downstream processing can be an effective and affordable method for manufacturing of large amount of mAbs, which is consistent with trends and regulatory support to consider continuous manufacturing.
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The use of Artificial Intelligence in the predictive modeling of Biosimilar production output
Vol.1(2); Pages:31-41. Published on November-2025
Abstract
Advanced process development Biosimilar manufacturing is a complex endeavor that requires predictive tools to improve process robustness and abridged development schedules. This work explores the use of biosimilar protein yield modeling through artificial intelligence (AI) to extrapolate behaviors in different process conditions. Random forests, neural networks and support vector regression algorithms were trained using historical data obtained on 120 large-scale fermentation runs. Among them all, the neural network model has shown the most accurate predictive results (R 2 =0.91), which are able to estimate production yields in terms of input variables such as dissolved oxygen, feeding strategy and agitation rates. External validation of 5 runs showed predictive errors less than eight percent. These findings indicate the possible use of AI-based models as decision support to catalyze process optimization and risk mitigation in biosimilar manufacturing at fast rates.
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Making Progress in the Formulation Development of Long-Acting Injectable Biopharmaceuticals: A Case Study of Interleukin-6 Inhibitors
Vol.1(2); Pages:42-50. Published on December-2025
Abstract
One way of ensuring patient adherence to chronic illnesses requiring biopharmaceuticals at regular intervals is to develop long-acting injectable (LIA) variants. In the present work, the formulation approaches towards sustained delivery of interleukin-6 (IL-6) inhibitors, namely biodegradable polymer microsphere and in-situ forming gels, were examined. The release kinetics determined in vitro indicated that the microspheres could offer an extended drug release lasting up to 21 days with great stability and reproducibility of the release; this was in contrast to the gel-based systems. Increased stability testing established that IL-6 inhibitors were structurally stable and active after formulation. In vivo PK analysis in rodent models demonstrated a long serum half-life and lower dosing frequency that did not affect the effectiveness of therapy. Such results confirm the clinical use of LAI formulations, which could improve the quality of life and treatment adherence of the patient.
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Issue 1 JANUARY- JUNE 2025
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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