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Updated: Jan 10, 2026

Rapid, Scalable Assembly and Loading of Bioactive Proteins and Immunostimulants into Diverse Synthetic Nanocarriers Via Flash Nanoprecipitation
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对高粘度寡核酸药物产品的PUPSIT实施挑战进行导航

Yu Zoe Zhang1, Joseph Perchiacca1, Anya Batalina2

  • 1Drug Product Development - Steriles, Medicine Development and Supply, GSK, 1250 S. Collegeville Ave, Collegeville, PA 19426, United States.

Journal of pharmaceutical sciences
|November 20, 2025
PubMed
概括

修订后的EU EMA附件1要求对无菌注射剂进行使用前后杀菌完整性测试 (PUPSIT). 本案例研究解决了PUPSIT对热敏感的寡核酸治疗药物的挑战,为行业合规提供了见解.

关键词:
在ASO的基础上,ASO是ASO.欧盟电子商务管理局附录-1过器灭菌方法 过器灭菌方法马辐射辐射的马辐射辐射.有氧核酸的部分.这是一个PUPSIT网站.聚乙硫 (PES) 过器的使用情况聚乙烯化物 (PVDF) 过器过器使用前,消毒后的完整性测试.

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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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