Industry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs) [0.03%]
难检注射剂产品的容器密封性策略行业指南
Klaus Wuchner,David Riesop,Carine Huon et al.
Klaus Wuchner et al.
Innovative modalities, such as antibody-drug conjugates (ADCs), radiopharmaceuticals (RPhs), and cell and gene therapies (CGTs), along with ultrahigh-concentration monoclonal antibody suspensions or high-concentration parenteral products, p...
Impact of spacer chain length on self-assembly of paclitaxel-biotin conjugates [0.03%]
含生物素紫杉醇连接物的自组装行为与连接链长度的关系研究
Dmitry V Beigulenko,Inna V Zhezher,Ekaterina S Kazakova et al.
Dmitry V Beigulenko et al.
Here we describe the synthesis and physicochemical evaluation of a series of paclitaxel-biotin conjugates with systematically varied linker lengths. The structure of the synthesized compounds was confirmed by NMR spectroscopy and HRMS. Elon...
A computationally informed framework for lipid-based formulation developability: Integrating predictive models with case studies [0.03%]
基于计算的脂质基药物制剂开发框架：预测模型与案例研究相结合
Callum D Ryan,Joseph P O&#x;Shea,Brendan T Griffin
Callum D Ryan
The increasing prevalence of poorly water-soluble drugs (PWSDs) in development pipelines has intensified the need for bio-enabling strategies such as lipid-based formulations (LBFs). However, formulation selection for optimal bioavailabilit...
Lux is not just lux: Method for determining the photostability of drug products [0.03%]
光照量度不只照度：测定药物制剂光稳定性的方法学研究
Mahmoud Tawfieq,Christina Lene Schneider,Kalle Kællberg Westring Woller-Nielsen et al.
Mahmoud Tawfieq et al.
Photostability is a critical factor influencing the quality and safety of drug products. This study presents a novel method to assess the photostability of drug products under indoor LED lighting, complementing certain aspects of but also c...
Madeline Berrow,Nichola J Starr,David J Scurr et al.
Madeline Berrow et al.
The National Institute for Health and Care Excellence recommend the routine use of topically applied chlorhexidine digluconate (CHX) formulations to eliminate skin microorganisms prior to incision to prevent surgical site infections (SSI). ...
Development of a melt-cast microneedle patch for sustained drug release of islatravir [0.03%]
一种用于Islatravir缓释的可熔铸微针贴片的开发研究
Mikayla L Rahman,Sijia Tao,Camryn Mekal et al.
Mikayla L Rahman et al.
Low adherence to daily oral drug regimens is a significant obstacle in effectively managing chronic therapies like HIV treatment, pre-exposure prophylaxis (PrEP), and contraception. While long-acting injectables eliminate the need for daily...
Dual-layer tissue scaffolds with antibacterial and regenerative properties: Integration of melt electrowriting and electrospray technologies [0.03%]
一种结合熔融电写技术和静电喷涂技术的具有抗菌和再生性能的双层组织支架
Irem Aydos,Sabereh Nouri,Sibel Daglilar et al.
Irem Aydos et al.
Efficient wound healing requires the design of advanced biomaterials that combine structural integrity, antimicrobial functionality, and the ability to promote tissue regeneration. The paper discusses the development of dual-layer tissue sc...
Multidisciplinary exploratory survey: Initial insights into biologic drug handling and regulatory perspectives among healthcare professionals [0.03%]
多学科探索性调查：生物药处置和监管视角的初步洞见——来自医护专业人员的观点
Léa Sorret,Nathalie Fuentes,Lara Nonis et al.
Léa Sorret et al.
Biologic drugs require specialized handling to maintain efficacy and safety, yet there is limited data on how healthcare professionals access information and comply with drug handling regulations. A 16-question survey was used to assess pro...
A quantitative metric of immune responses with applications in vaccines, cancer immunity, autoimmunity, and anti-drug antibody monitoring [0.03%]
一种免疫反应的量化指标及其在疫苗、癌症免疫、自身免疫和药物抗抗体监测中的应用
Indiwari Gopallawa,Surendra Chavan,Arvind Goswami et al.
Indiwari Gopallawa et al.
Advances in immunotherapies across cancer, vaccines, autoimmunity, and biologics have highlighted the critical need for comprehensive metrics that capture immune dynamics beyond traditional reductionist measures such as antibody levels, lym...
Comprehensive stress study on recombinant adeno-associated virus vectors: Evaluating the capabilities of established analytical techniques [0.03%]
重组腺相关病毒载体的全面应力研究：评估 established 分析技术的能力
Jakob Heckel,Lukas Bongers,David Naylor et al.
Jakob Heckel et al.
Recombinant adeno-associated virus (rAAV) vectors are prominent vectors for in-vivo gene therapies. However, achieving consistent product quality is a major challenge due to the inherent complexity of their structure and the associated prod...