Forced degradation analysis of recombinant adeno-associated virus serotype 8 based on analytical anion exchange chromatography coupled to orthogonal characterization [0.03%]
基于分析阴离子交换色谱与正交表征偶联的重组腺相关病毒八型强制降解研究
Zhuolun Yang,Yuki Yamaguchi,Xiaofang Lyu et al.
Zhuolun Yang et al.
As a leading vector for gene therapy, recombinant adeno-associated virus (rAAV) has been widely investigated and used. Forced degradation analysis is required to understand the molecular properties and stability of rAAV. In this study, we h...
Evaluation of DMSO extraction efficiency compared to other solvents on representative polymeric materials used in biologics production [0.03%]
评估DMSO与其他溶剂从生物药生产中使用的代表性聚合材料中提取的效率
Ting Cheng,Praveen Kumar,Noorunnisa Rasheed et al.
Ting Cheng et al.
Single-use systems (SUS) are increasingly employed in biopharmaceutical manufacturing, including advanced therapy medicinal products (ATMP) and antibody-drug conjugates (ADC). Dimethyl sulfoxide (DMSO), commonly used at 5-10 % in cell and g...
Development of injectable ibuprofen and resveratrol co-loaded mesoporous silica nanoparticle-based hydrogels for sustained delivery in osteoarthritis management [0.03%]
用于软骨组织工程的载有缓释异丁苯丙酸酯和白藜芦醇中孔硅基纳米复合水凝胶的制备及表征用于关节炎管理注射用异布芬和白藜芦醇共负载介孔硅纳米颗粒为基础的水凝胶的开发以实现持续输送
Mithun Rajendra Dethe,Hafiz Ahmed,Nazir Hussain et al.
Mithun Rajendra Dethe et al.
This study reports the synthesis of mesoporous silica nanoparticles (MSNs), MCM‑41 (M41) and SBA‑15 (S15), individually loaded with ibuprofen (M41IF, S15IF) and resveratrol (M41RS, S15RS). These drug‑loaded MSNs were formulated into ther...
Freezing and thawing of biologics in bottles and downscale modelling evaluation [0.03%]
瓶装生物药的冻融及小规模工艺评估研究
Mostafa Nakach,Catarina Corriea,Jean-René Authelin et al.
Mostafa Nakach et al.
Freezing and thawing are critical steps in the manufacturing of biologics, as they help preserve product quality during storage and transport. However, these processes can also introduce stresses that affect protein stability. This study in...
Navigating ADME profiling challenges in microphysiological systems: Evaluation of a liver-chip model for clearance prediction [0.03%]
微生理系统中的ADME评价挑战：评估肝脏芯片模型的清除预测能力
Lina Mettler,Julia Riede,Felix Huth et al.
Lina Mettler et al.
Accurate prediction of the hepatic clearance in humans is essential during pre-clinical drug development. As conventional in vitro models do not replicate the complexity of the human liver physiology, hepatocyte-specific functions are rapid...
Intranasal delivery of chitosan-coated bilosomes for repurposing Olmesartan in Alzheimer's disease therapy: Formulation, optimization, pharmacokinetic and pharmacodynamic evaluation [0.03%]
壳聚糖包被的双室脂质体鼻给药递送奥美沙坦治疗阿尔茨海默病：制剂、优化、药动学和药效学评价
Ghada Abdelsabour Moubarak,Alaa H Salama,Adel A Ali et al.
Ghada Abdelsabour Moubarak et al.
Alzheimer's disease (AD) is a neurological illness that progresses over time and has limited therapeutic options. This is mostly because the blood-brain barrier prevents drugs from reaching the brain efficiently. This study sought to repurp...
Artificial Intelligence in Pharmaceutical Manufacturing: Applications, Case Studies, and GxP Implementation Considerations [0.03%]
制药制造中的人工智能应用：应用、案例研究及GXP实施考虑因素
Gowtham Nakka,Sakshi Gupta,Katti Kartik Reddy
Gowtham Nakka
Artificial intelligence (AI) and machine learning (ML) applications are starting to be employed within the pharmaceutical manufacturing industry to create better process controls and real-time process monitoring and inspection systems for b...
Dissolution-Microdialysis predicts oral bioavailability from phospholipid-based amorphous solid dispersions [0.03%]
基于磷脂的无定形固态分散体口服生物利用度的预测：溶解-微透析法
Felix Paulus,Mikkel Højmark Tønning,Annette Bauer-Brandl et al.
Felix Paulus et al.
Here, we report dissolution of aprepitant from three phospholipid-based amorphous solid dispersions (ASDs), namely binary ASDs containing drug and either natural or hydrogenated phospholipid (HPL) and a ternary ASD containing HPL and hydrox...
Stabilization of supersaturation for enhanced oral absorption of a BCS II drug efonidipine hydrochloride: Eudragit® L100-55-based amorphous solid dispersions [0.03%]
基于Eudragit L100-55的无定形固体分散物增强BCS II类药物苯磺酸伊那么利口服吸收的过饱和状态稳定化研究
Song Huang,Yiqi Tian,Jiaxin Gao et al.
Song Huang et al.
Supersaturation is a widely employed strategy to improve the oral bioavailability of poorly soluble drugs, but its application is usually limited by rapid recrystallization. This study aimed to investigate the solubilization and crystalliza...
Effect of HI-6-loaded brain-targeted metal-organic frameworks on reactivation of central nervous system enzymes [0.03%]
载HI-6的金属有机框架脑靶向给药对中枢神经系统胆碱酯酶再活化的效果研究
Yanhui Qin,Qian Li,Ning Fan et al.
Yanhui Qin et al.
Organophosphate poisoning seriously endangers human life and health. Due to the existence of the blood-brain barrier, most drugs are difficult to reach the effective therapeutic concentration in the brain, thus affecting the effect of centr...