在生物治疗制剂的配方中,在超过过程中保持洗剂/表面活性剂
Liang-Kai Chu1, Zhuoshi Du1, Matthew Billups1
1Department of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, USA.
Biotechnology progress
|February 19, 2025
概括
在超过过程中聚酸盐的保留是复杂的,因为单体和. 一个新的模型准确地预测了聚酸盐的传输,有助于生物制药工艺设计.
科学领域:
- 生物制药制造业 生物制药制造业
- 分离科学 分离科学
- 聚合物科学 聚合物科学
背景情况:
- 像聚酸盐这样的表面活性剂是生物制药生产中必不可少的辅助剂.
- 预测超过过程中表面活性剂的保留是具有挑战性的,因为单体-微粒平衡.
- 了解聚酸盐的行为对于优化净化过程至关重要.
研究的目的:
- 通过不同类型的膜和分子量切断点在超过过程中研究聚酸盐保留.
- 评估度极化对表面活性剂传播的影响.
- 开发一个用于超过中聚酸盐行为的预测模型.
主要方法:
- 使用纤维素和聚硫膜 (10,30,100 kDa MWCO) 的超试验.
- 流量渐进实验,以评估度极化效应.
- 开发和验证聚酸盐传输的数学模型.
主要成果:
- 随着度的增加,由于菌根的保留,聚酸20的传播显著下降.
- 由于吸附,聚硫膜的传输率低于纤维素膜.
- 开发的模型准确地预测了实验性聚酸盐传输数据.
结论:
- 聚酸盐的保留取决于度,膜物质以及单体和粒的存在.
- 度极化显著影响了超过过程中表面活性剂的传递.
- 数学模型为设计和优化生物制药超过/透过过程提供了宝贵的工具.
相关概念视频
Detergent Purification of Membrane Proteins
5.1K
Detergents are used to purify the integral proteins of the membrane. The hydrophobic portion of the detergent can replace membrane phospholipids while solubilizing the membrane proteins. When detergent monomers reach a specific concentration in a solution called critical micelle concentration (CMC), they form micelles. Above CMC, the concentration of the detergent monomers remains in equilibrium with the micelle. The number of detergent monomers present in the CMC varies for each detergent, and...
5.1K
Factors Influencing Drug Absorption: Pharmaceutical Parameters
113
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
113
Factors Affecting Dissolution: Particle Size and Effective Surface Area
677
Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
677
Drug Elimination by Renal Route: Tubular Secretion
2.1K
Once the process of glomerular filtration is completed, blood carrying unfiltered drug molecules traverses through efferent arterioles and makes its way into the peritubular capillaries in the proximal tubule. A variety of carriers play a pivotal role in actively secreting drugs from these peritubular capillaries into the tubular fluid. The organic anion transporter transfers acidic drugs, against an electrochemical gradient, from the peritubular capillaries into the renal tubule cells and...
2.1K
Drug Elimination by Renal Route: Tubular Reabsorption
3.1K
During the process of renal excretion, as the glomerular filtrate progresses to the distal convoluted tubule (DCT), drugs that are highly permeable, lipophilic, and nonionized undergo passive reabsorption from the tubular fluid into the surrounding peritubular capillaries. This reabsorption process restricts their elimination through the kidneys. However, the majority of drugs are either weak acids or weak bases, and their ionization level is dependent on pH. By altering the pH of urine, the...
3.1K
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
171
Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
171


