Monoclonal antibodies (mAbs) have become essential therapeutics for treating various diseses. The high cost of goods is the main barrier to universal access and equitable distribution of these therapeutics. ‘End-to-end continuous bioprocessing can significantly reduce the cost of goods, increase manufacturing robustness, and reduce the ecological footprint of biopharmaceutical manufacturing of mAbs,’ is one of the important conclusions from the report discussed here. 

Continuous manufacturing is emerging as a key innovation in the biopharmaceutical sector, offering benefits such as reduced operational space, alongside enhanced product quality through improved process monitoring. This all translates into higher productivity. The authors in the discussed report perform a rigorous economic efficiency assessment to evaluate the cost-effectiveness of continuous processing in mAb production.

Companies are gradually considering integrating these methods by using a hybrid approach, blending batch and continuous processes. This strategy has led to notable advances in both upstream and downstream processing, such as better cell expression, bioreactor control, and continuous techniques for product capture, purification, and formulation. These improvements, often utilizing single-use (SU) systems for efficiency and ease of operation, are paving the way for lower costs, minimization of human error, and consistently higher quality in biopharmaceutical production.

In the report the robustness of continuous processes is examined to understand the risks and uncertainties inherent in mAb production, especially within the complex environment of mixed-product facilities due to variance in therapeutic product demand.

The results demonstrate that, compared with an optimized best-in-class fed-batch process (with 15 g/l titer and multicolumn chromatography), continuous manufacturing can reduce the total annual production costs, facility footprint, plastic waste, and CO2 emissions by up to 23%, 51%, 57%, and 54%, respectively.

This research report, has been assembled by an interdisciplinary team of experts from Sartorius and Just-Evotec Biologics, and it leverages extensive knowledge in continuous biomanufacturing. Through this exploration, a data-driven foundation is provided for policy and decision-making, augment process reliability, enhance risk management, and fortify industry confidence in continuous processing methods amid the complex challenges of biopharmaceutical production.

Bron: www.sciencedirect.com

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