Effect of surfactants on agitation-induced submicron and subvisible particles of therapeutic proteins [0.03%]
表面活性剂对治疗性蛋白质搅拌诱导的亚微米和次可见颗粒的影响
Kosei Shibata,Arni Gambe-Gilbuena,Kimitoshi Takeda et al.
Kosei Shibata et al.
The formation of submicron and subvisible particles (SMPs and SVPs) is increasingly recognized as an important quality and safety concern for biopharmaceutical products. In this study, we aimed to quantitatively assess the effectiveness of ...
Process development to overcome drug substance agglomeration and restore dissolution performance [0.03%]
克服药物物质聚集并恢复溶解性能的工艺开发
Mayank Singhal,Kalyan Nidadavole,Dean S Murphy et al.
Mayank Singhal et al.
Dissolution testing is performed to understand the rate and extent of drug release for assurance of in vivo bioavailability. In this case study, an immediate-release tablet of an investigational BCS Class II compound exhibited slow and inco...
A framework for plasma protein binding: Comparing methods for diverse small molecules and adapting for novel modalities [0.03%]
一种用于血浆蛋白结合的框架：比较不同小分子的方法并适应新模态
Zachary Enlo-Scott,Victor Dudal,Maja Gredelj et al.
Zachary Enlo-Scott et al.
Reliable measurements of plasma protein binding (PPB) are essential for determining a drug's therapeutic window and understanding pharmacokinetic/pharmacodynamic (PK/PD) relationships. This study evaluates the concordance of the three prima...
Correlation between protein-polydimethylsiloxane visible particle formation and computationally derived antibody surface properties [0.03%]
蛋白质-聚二甲基硅氧烷可见颗粒形成与抗体表面性质的计算特征的相关性研究
Kazunori Hirayama,Kengo Arai,Masakazu Fukuda et al.
Kazunori Hirayama et al.
Proteinaceous visible particles (pVPs) form through protein adsorption and aggregation at interfaces. Their formation risk varies widely among biopharmaceutical proteins. We developed a computational chemistry approach to quantitatively com...
An approach for the evaluation of closed system drug-transfer devices for transfer accuracy, particle release, and material-of-construction information [0.03%]
用于转移准确度、微粒释放和材质信息评估的密闭系统药物转运装置的方法
Christian Lehermayr,Sy Gebrekidan,Serene Jabary et al.
Christian Lehermayr et al.
A Closed System Drug-Transfer Device (CSTD) is designed to prevent hazardous drugs from escaping their containers, thereby effectively safeguarding healthcare professionals from potential exposure. However, variations among CSTD designs may...
Change management considerations for orally inhaled and nasal drug products and other drug device combination products in the European Union [0.03%]
欧盟口服吸入和鼻用药品及其他药械组合产品的变更管理考虑因素
Marielle Calderini,Beatrice Grand-Demars,Lee Nagao
Marielle Calderini
In this paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), discusses the current regulatory landscape associated with change management of orally inhaled and nasal drug products (OINDP) and other...
Perfluorocarbon-liquid interface culture method enhances mucus production and allows evaluation of drug permeability through the mucus layer [0.03%]
全氟碳液体界面培养方法增强粘液产生并允许评估药物通过粘液层的渗透性
Hisanao Kishimoto,Haruka Takano,Haruka Umezawa et al.
Hisanao Kishimoto et al.
Pulmonary drug administration is a promising route for systemic delivery of therapeutics. Airway epithelial cells cultured under air-liquid interface (ALI) conditions are commonly used to evaluate drug permeation across differentiated epith...
Stabilization of spray-dried monoclonal antibody formulations with polymeric excipients [0.03%]
聚合物辅料稳定喷雾干燥单克隆抗体配方
Chanakya D Patil,Kinnari Santosh Arte,Rachana Sapkota et al.
Chanakya D Patil et al.
Spray drying is an emerging continuous manufacturing approach with significant potential for producing stable solid formulations of biologic drug products such as peptides, proteins and oligonucleotides. However, these sensitive molecules o...
Identification of a diastereomer of penicilloic acid during acid-mediated degradation of 6-aminopenicillanic acid [0.03%]
6-氨基青霉烷酸酸介导降解过程中发现的青霉酸的一种差向异构体的鉴定
Sofia Sontacchi,Giulia Martelli,Sofia Martello et al.
Sofia Sontacchi et al.
6-Aminopenicillanic acid (6-APA), the core scaffold of penicillin antibiotics, is a key intermediate in the industrial synthesis of β-lactam drugs but it is prone to degradation under acidic conditions due to the strain of the β-lactam ri...
Maria Clara Novaes-Silva,David Quéré,Mostafa Nakach et al.
Maria Clara Novaes-Silva et al.
Fogging inside pharmaceutical vials during freeze-drying can compromise product appearance, leading to vials rejection and significant economic losses. Although the Marangoni effect has been invoked to understand this phenomenon, direct exp...