Mechanism-informed evaluation of particle formation in high-concentration monoclonal antibodies during fill-finish: Impact of pump materials, surface interactions, and system architecture [0.03%]
基于机理的评估高浓度单克隆抗体在灌装过程中颗粒形成的影响：泵材质、表面相互作用和系统架构的影响
Adam Hartman,Deep Bhattacharya,Mingyue Li et al.
Adam Hartman et al.
Particle formation during fill-finish operations poses a critical risk to the quality and manufacturability of high-concentration monoclonal antibody drug products. This study systematically evaluates the influence of pump material, clearan...
Investigating adeno-associated virus stabilization at the air-water interface through competitive adsorption [0.03%]
通过竞争吸附研究腺相关病毒在气液界面的稳定化问题
Julie Garcia Gonzalez-Calero,Harri Rahn,Kan Wu et al.
Julie Garcia Gonzalez-Calero et al.
This study investigated the stabilization of adeno-associated viruses (AAVs) at the air-water interface (AWI), focusing on the interplay between surfactant and capsid adsorption during agitation stress. AAV-9 and its engineered variant, AAV...
Non-viral in vivo cell and gene therapies: A change journey for CMC science and scientists [0.03%]
无病毒体内细胞和基因疗法：CMC科学及科学家的变革之旅
Annette Bak,Marianne Ashford
Annette Bak
The CMC (Chemistry Manufacturing and Controls) landscape is rapidly evolving as pharmaceutical science shifts from traditional small molecules and peptides towards non-viral in vivo cell and gene therapies. The article highlights the skills...
Effect of transcript length, temperature, and lyophilization on mRNA-lipid nanoparticle stability [0.03%]
转录长度、温度和冷冻干燥对mRNA-脂质纳米颗粒稳定性的影响
Manasa Chillara,Weibo Zhao,Jonathan S Dordick et al.
Manasa Chillara et al.
Lyophilization enhances the long-term stability of mRNA-lipid nanoparticles (LNPs), yet the full extent of the physicochemical and functional implications of freeze-drying remains underexplored. In the current work, the influence of key var...
Zeolitic imidazolate frameworks for delivery of repurposed drugs with anti-chikungunya activity [0.03%]
用于抗奇昆古尼亚热药物再利用的咪唑化石油架框架载体
Rutuja Jagtap,Kalichamy Alagarasu,Poonam Patil et al.
Rutuja Jagtap et al.
Chikungunya virus (CHIKV) is a major global concern due to its emergence and re-emergence and the lack of effective antiviral treatments. Conventional antiviral drugs struggle with poor bioavailability, rapid degradation, and cytotoxicity, ...
A predictive model for paracellular solute transport across vascular endothelia: Quantitative insight into factors affecting subcutaneous absorption [0.03%]
血管内皮细胞间溶质转运的预测模型：定量剖析影响皮下吸收的因素
Krishnaveni Thota,Anitha Mogilicharla,Vasanthakumar Sekar et al.
Krishnaveni Thota et al.
This study presents a predictive computational model that simulates drug absorption across vascular endothelia after subcutaneous (SC) injection of small hydrophilic drugs (
Divergent host cell protein profiles during special purification of biologics from prokaryotic versus eukaryotic systems dictate the need for tailored ELISA assay development [0.03%]
从原核和真核系统特殊纯化生物制品产生的宿主细胞蛋白谱型差异决定了定制ELISA测定方法的必要性
Ran Zhang,Yue Yu,Zuxia Zhou et al.
Ran Zhang et al.
Therapeutic antibodies are expressed via host systems, such as Chinese hamster ovary (CHO) cells and Escherichia coli (strain B / BL21-DE3, E.coli BL21), followed by purification to remove host cell proteins (HCPs), thereby averting risks i...
Chemoenzymatic synthesis of a CD19/CD20 bispecific nanobody-rhamnose conjugate with reconstituted Fc effector functions for immunotherapy of B-cell malignancies✰ [0.03%]
用于B细胞恶性肿瘤免疫治疗的CD19 / CD20双特异性纳米抗体-半乳糖醛酸糖苷共轭物的化学酶合成，并重新构建Fc效应功能⭐
Yu Zhu,Wenxian Cao,Zhouyi Shi et al.
Yu Zhu et al.
Recent advances in bispecific agents targeting both CD19 and CD20 highlight their potential as an effective strategy for improving clinical outcomes in B-cell malignancies. Herein, we developed a CD19/CD20 bispecific nanobody, 19Nb1-20Nb2, ...
Resolving drug release mechanisms of amorphous solid dispersions using optical coherence tomography [0.03%]
应用光学相干层析法解析固态药物释放机制
Daniel Powell,Ecaterina Bordos,John Robertson et al.
Daniel Powell et al.
This study presents an integrated approach utilising optical coherence tomography (OCT) to investigate the drug release mechanisms of hot-melt extruded (HME) amorphous solid dispersions (ASDs) of ritonavir and Soluplus®. Ritonavir-Soluplus...
Metronidazole and cefuroxime concentrations in tunnelized facial artery myomucosal island flaps [0.03%]
甲硝唑和头孢呋辛在面部动脉肌粘膜带蒂岛 flap 中的浓度分布研究
Pelle Hanberg,Johanne Ravn Hansen,Sara Hillerup et al.
Pelle Hanberg et al.
Tunnelized Facial Artery Myomucosal (FAMM) island flaps are used for reconstruction after oral cavity cancer surgery but may be vulnerable to compromised perfusion. This study evaluated the tissue concentrations of cefuroxime and metronidaz...