推进单克隆抗体制造:工艺优化、成本降低策略和新兴技术。

IF 5.3 Q1 MEDICINE, RESEARCH & EXPERIMENTAL
Biologics : Targets & Therapy Pub Date : 2025-04-09 eCollection Date: 2025-01-01 DOI:10.2147/BTT.S515078
Ranjit Ranbhor
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引用次数: 0

摘要

目的:本文综述了单克隆抗体(mAb)制造的最新进展,重点是工艺优化、成本降低策略和新兴技术。该分析解决了当前制造过程中的关键挑战,同时评估了提高生产效率和经济可行性的创新解决方案。方法:我们对单克隆抗体制造的最新文献进行了全面分析,检查了传统的批量加工、连续加工和混合系统。该报告评估了成本优化策略,包括媒体开发和流程集成,同时评估了机器学习和高级分析等新兴技术对制造效率的影响。结果:最近的研究表明,与传统的批量加工相比,连续加工可以节省高达35%的成本,以满足每年100-500公斤的生产需求,尽管这种收益在更大规模的情况下会减少。混合动力设施的盈亏平衡点更快,比传统设施早2-2.5年实现盈利。先进的媒介优化策略,结合新的三肽递送方法,已经证明单克隆抗体滴度提高了35%。机器学习和高级分析的集成大大增强了过程控制和优化能力。结论:单抗制造技术的发展为提高生产效率和降低成本提供了有希望的途径。在选择最佳制造策略时,规模依赖因素仍然至关重要,而新兴技术为工艺优化提供了新的机会。未来在连续处理、高级分析和细胞系工程方面的发展将对满足日益增长的全球需求至关重要,同时确保单抗治疗药物的经济可行性和可及性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Advancing Monoclonal Antibody Manufacturing: Process Optimization, Cost Reduction Strategies, and Emerging Technologies.

Purpose: This review examines recent advances in monoclonal antibody (mAb) manufacturing, focusing on process optimization, cost reduction strategies, and emerging technologies. The analysis addresses critical challenges in current manufacturing processes while evaluating innovative solutions to improve production efficiency and economic viability.

Methods: We conducted a comprehensive analysis of recent literature on mAb manufacturing, examining traditional batch processing, continuous processing, and hybrid systems. The review evaluates cost optimization strategies, including media development and process integration, while assessing the impact of emerging technologies, such as machine learning and advanced analytics, on manufacturing efficiency.

Results: Recent studies demonstrate that continuous processing can achieve up to 35% cost savings compared to traditional batch processing to meet an annual production demand of 100-500 kg, though this gain diminishes at larger scales. Hybrid facilities show accelerated break-even points, reaching profitability 2-2.5 years earlier than traditional facilities. Advanced media optimization strategies, incorporating novel tripeptide delivery methods, have demonstrated up to 35% improvement in mAb titers. Integration of machine learning and advanced analytics has significantly enhanced process control and optimization capabilities.

Conclusion: The evolution of mAb manufacturing technologies offers promising pathways for improving production efficiency and reducing costs. Scale-dependent considerations remain crucial in selecting optimal manufacturing strategies, while emerging technologies present new opportunities for process optimization. Future developments in continuous processing, advanced analytics, and cell line engineering will be essential in meeting growing global demand while ensuring economic viability and accessibility of mAb therapeutics.

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来源期刊
Biologics : Targets & Therapy
Biologics : Targets & Therapy MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
8.30
自引率
0.00%
发文量
22
审稿时长
16 weeks
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