Stabilization of spray-dried monoclonal antibody formulations with polymeric excipients
📄 英文摘要 English Abstract
Spray drying is an emerging continuous manufacturing approach with significant potential for producing stable solid formulations of biologic drug products such as peptides, proteins and oligonucleotides. However, these sensitive molec... Optimizing high-drug-loaded spray-dried antibody fragment formulations for sustained delivery: influence of excipient composition and humidity on long-term stability Aaps Open
📄 中文摘要 Chinese Abstract
📋 英文结构化总结 English Structured Summary
摘要整理
Background:
Spray drying is an emerging continuous manufacturing approach with significant potential for producing stable solid formulations of biologic drug products such as peptides, proteins and oligonucleotides. The provided text also identifies the study focus as optimizing high-drug-loaded spray-dried antibody fragment formulations for sustained delivery, with attention to the influence of excipient composition and humidity on long-term stability.
Methods:
N/A - not provided in the provided text, except that the title indicates optimization of high-drug-loaded spray-dried antibody fragment formulations and assessment of excipient composition and humidity on long-term stability.
Results:
N/A - not provided in the provided text.
Data Summary:
N/A - not provided in the provided text.
Conclusions:
N/A - not provided in the provided text.
Practical Significance:
The work is relevant to producing stable solid formulations of biologic drug products and to sustained delivery of high-drug-loaded spray-dried antibody fragment formulations.
📋 中文结构化总结 Chinese Structured Summary
背景:
喷雾干燥是一种新兴的连续制造方法，在制备肽、蛋白质和寡核苷酸等生物药物产品的稳定固体制剂方面具有巨大潜力。所提供的文本还指出，本研究聚焦于优化高载药量喷雾干燥抗体片段制剂以实现持续给药，并关注辅料组成和湿度对长期稳定性的影响。
方法:
不适用——提供文本中未给出，但标题表明研究内容为优化高载药量喷雾干燥抗体片段制剂，并评估辅料组成和湿度对长期稳定性的影响。
结果:
不适用——提供文本中未给出。
数据摘要:
不适用——提供文本中未给出。
结论:
不适用——提供文本中未给出。
实际意义:
该工作与制备生物药物产品的稳定固体制剂以及高载药量喷雾干燥抗体片段制剂的持续给药相关。