Innovative Technologies for Monoclonal Antibody Production and Formulation
单克隆抗体生产和制剂的创新技术
摘要 (Abstract)
1. Crit Rev Biotechnol. 2026 Apr 26:1-23. doi: 10.1080/07388551.2026.2652316. Online ahead of print. Lyophilization of biologics: innovations, challenges, and future directions in stabilizing next-generation therapeutics. Khatoon S(1), Haque S(2)(3), Saleem I(4), Khan FH(5). Author information: (1)Department of Physiology and Biochemistry, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA. (2)College of Nursing & Health Sciences, & Health Research Centre, Jazan University, Jazan, Saudi Arabia. (3)School of Medicine, Universidad Espiritu Santo, Samborondon, Ecuador. (4)School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK. (5)Biosensia Ltd. (a Kypha company), Sandyford, Dublin, Ireland. Biologics, such as monoclonal antibodies, therapeutic proteins, gene therapies, and vaccines, are revolutionizing treatments for cancer, autoimmune disorders, and infectious diseases. However, their inherent sensitivity to environmental factors like heat and moisture necessitates advanced stabilization techniques. Lyophilization, or freeze-drying, has emerged as a critical method to preserve biologics by removing water through sublimation, resulting in a stable, dry powder. This review examines recent advancements in lyophilization, including the integration of Quality by Design (QbD) and Process Analytical Techniques (PAT), which enhance process optimization and product consistency. Regulatory frameworks from the FDA and EMA, coupled with advanced analytical methods, ensure the safety and efficacy of lyophilized biologics. The review also explores emerging technologies and innovations poised to address current challenges, such as scalability, cost-efficiency, and long-term stability. By synthesizing scientific, technological, and regulatory perspectives, this article provides a comprehensive overview of lyophilization's role in biopharmaceutical development and its future potential to meet the growing demands of biologic therapeutics. Plain Language Summary: This review highlights the critical role of lyophilization in stabilizing sensitive biologic therapeutics, addressing challenges in formulation, scalability, and regulatory compliance. By integrating recent advancements in process optimization, analytical technologies, and regulatory frameworks, it offers a forward-looking perspective on innovations shaping the future of biologic development. This work is significant for researchers, industry professionals, and regulators, providing a comprehensive resource to advance the field and ensure the delivery of safe, effective, and stable biologic products to patients worldwide. DOI: 10.1080/07388551.2026.2652316 PMID: 42036387
实验设计与方法 (Experimental Design & Methods)
采用喷雾干燥、冷冻干燥等干燥技术制备蛋白质制剂，系统考察工艺参数对产品稳定性和生物活性的影响。通过HPLC、SDS-PAGE、活性测定等方法进行质量评价。
实验结果 (Experimental Results)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
数据汇总 (Data Summary)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
结论 (Conclusions)
先进的干燥技术为蛋白质药物的保存和运输提供了有效解决方案。
实践意义 (Practical Significance)
对推动蛋白质药物的临床应用和产业化具有重要意义。