对于过器冲洗测定小规模模型选择的关键考虑:关于聚硫膜过器的案例研究
Sameera Sansare1, James Mutino1, Sonia Bedi1
1Formulation Development Group, Regeneron Pharmaceuticals, Inc, USA.
Journal of pharmaceutical sciences
|September 21, 2025
概括
使用合聚硫 (PES) 过器的无菌过显示了二次聚酸盐80吸附峰值,在非合的配置中不存在. 这表明合过器在冲洗研究中的表现与非合过器模型不同.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过技术过技术的使用
- 生物加工是一种生物加工.
背景情况:
- 无菌过对于亲肠道药品制造至关重要.
- 过膜可以吸附蛋白质/表面活性剂,并释放可漏物.
- 折叠过器囊最大限度地提高了膜表面的过面积.
研究的目的:
- 为了研究在折叠过器中观察到的二次聚酸盐80吸附峰值.
- 为了比较合和非合聚硫 (PES) 过器的性能.
- 为了评估过器配置和流量对吸附特性的影响.
主要方法:
- 使用高度单克隆抗体配方进行过器冲洗研究.
- 合式和非合式PES过膜的比较.
- 分析了聚酸盐80吸附,保持了一致的体积与表面积比.
主要成果:
- 检测到的二次聚酸80吸附峰值仅在的PES过器中.
- 过器流量没有显著影响次要峰值的发生.
- 折叠膜的平坦化消除了二次峰值,这表明了取决于配置的效应.
结论:
- 叠加过器配置与非叠加过器相比,具有不同的性能特征.
- 在冲洗研究中,非折叠的PES过器可能无法准确地模拟折叠囊过器的行为.
- 了解波器配置效应对于准确的流程开发和风险评估至关重要.
更多相关视频
10:37Procedure to Evaluate the Efficiency of Flocculants for the Removal of Dispersed Particles from Plant Extracts
Published on: April 9, 2016
9.3K
09:38Fabrication Procedures and Birefringence Measurements for Designing Magnetically Responsive Lanthanide Ion Chelating Phospholipid Assemblies
Published on: January 3, 2018
7.5K
相关概念视频
Filtration
4.9K
Filtration is a physical separation process that involves passing a suspension through a porous medium to separate solids from fluids. During filtration, solids collect on the porous medium while liquids, also collectively known as the filtrate, pass through. The filtration medium is selected based on the filtration purpose, quantity, and nature of the precipitate. The general criteria for a suitable filtering medium are that it is inert, mechanically strong, nonabsorbent toward dissolved...
4.9K
Size-Exclusion Chromatography
1.7K
In size-exclusion chromatography (SEC), also known as molecular-exclusion or gel-permeation chromatography, molecules are separated based on their sizes. This technique is important for separating large molecules such as polymers and biomolecules. The two classes of micron-sized stationary phases encountered in SEC are silica particles and cross-linked polymer resin beads. Both materials are porous, but their pore sizes vary significantly.
Silica particles offer advantages such as rigidity,...
Silica particles offer advantages such as rigidity,...
1.7K
