The International Journal of Biopharmaceutical Manufacturing and Therapeutic Advances (IJBMTA) is committed to providing immediate and unrestricted access to the latest scientific advancements in the field. Our Current Issue features peer-reviewed articles highlighting innovative research, industrial developments, and therapeutic breakthroughs.
Featured Articles in the Latest Issue
- 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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