Study of LAL and Recombinant Cascade Reagents Methods for Bacterial Endotoxin Testing in Pharmaceutical Products [0.03%]
凝胶法和重组胶质反应试剂法定量测定药品内毒素的研究
Dr Prasad Thota,Piyush Kumar,Dr Anil Kumar Teotia et al.
Dr Prasad Thota et al.
The bacterial endotoxin method uses amoebocyte lysate reagents from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus) to detect and quantify bacterial endotoxin in injectable medications and medical devices. Two types of rec...
The high risk of mold contamination in biopharmaceutical facilities: gypsum wall materials versus uPVC wall panels â regulatory scrutiny, recalls and facility shutdowns [0.03%]
生物制药设施中霉菌污染的高风险：空心石膏墙材料与UPVC墙板的对比监管审查、召回和工厂停产
Maik Jornitz
Maik Jornitz
Mold contamination in biopharmaceutical manufacturing is a serious patient-safety, product-quality and regulatory risk. This paper reviews the mechanisms by which wall construction materials contribute to microbial ingress and colonization,...
Bridging Guidance and Regulation: Interpreting the Draft Annex 22 on Artificial Intelligence in GMP Manufacturing [0.03%]
从GMP生产角度解读人工智能指导原则草案附件22：促进指引与规范间的衔接性
Mario Stassen,Matt Schmucki,Fransisco Barranco et al.
Mario Stassen et al.
This paper builds upon Stassen et al. (2025), "Recommendations for Artificial Intelligence Application in Continued Process Verification," to provide a detailed interpretation of the European Medicines Agency (EMA) Draft Annex 22 - Artifici...
Design Differences and Usability Risks in GLP-1 Pen Injectors: A Comparative Study of a Generic and Reference Device [0.03%]
GLP-1笔式注射器的设计差异及可用性风险：通用设备与参照设备的比较研究
Laurie Brunet-Manquat,Anne Combedazou,Claire Ramus et al.
Laurie Brunet-Manquat et al.
Objective: To provide preliminary insights into whether a proposed generic combination product injector for glucagon-like peptide-1 (GLP-1) receptor agonist administration can be substituted for the delivery device consti...
LC-MS/MS-Based Determination of Gadobutrol Residues for Pharmaceutical Cleaning Validation [0.03%]
基于LC-MS/MS的药品清洁验证用 gadobutrol残留测定
Gözde Gülin İnan,İbrahim Daniş,Neşet Neşetoğlu et al.
Gözde Gülin İnan et al.
The hazards of gadolinium, widely used in magnetic resonance imaging to detect pathological lesions, should not be overlooked. Due to its pharmacological effects, any contamination from gadobutrol production poses serious health risks. Ther...
Neural Network Prediction of Response Factors for Extractables and Leachables in Pharmaceuticals and Medical Devices [0.03%]
药物和医疗器械中可提取物和浸出物响应因子的神经网络预测方法研究
Yuanlin Deng,Anthony Grice,Michael Louis et al.
Yuanlin Deng et al.
Ensuring safety of patients using pharmaceuticals and medical devices through chemical characterization requires accurate estimation of extractables and leachables to ensure tolerable risk from unintentional exposure to these chemicals. How...
A QbD Framework for Efficient Technology Transfer in Biologics Manufacturing [0.03%]
基于质量的设计在生物制品制造中的高效技术转移框架
Dogan Ornek
Dogan Ornek
Technology transfer from clients to contract development and manufacturing organizations is a complicated process and inclusion of scale-up and scale-down strategies brings additional complexity. These complexities can lead to extended deve...
Non-sterile Drug Products - Microbiologically Related Recalls and Compliance Issues [0.03%]
微生物相关事件导致的非无菌药品召回及合规问题
Edward C Tidswell
Edward C Tidswell
Non-sterile drug products represent approximately 30% of annual drug sales. Non-sterile drug products offer therapeutic advantages, manufacturing costs which permit wide patient access, versatility of dosage form and routes of administratio...
Reproducible and Efficient Phenotyping for Cell Therapy Manufacturing Using the Accellix Automated Flow Cytometer Platform [0.03%]
用于细胞治疗制造的Accellix自动化流式细胞仪平台的可重复性和高效表型分析
Jacob Van Vloten,Seungmi Yoo,Gurleen Sandhu et al.
Jacob Van Vloten et al.
Measuring cellular quality attributes of cell therapy products is crucial because it ensures their safety, purity, potency, identity, and stability. These attributes help determine whether the therapy is effective and consistent across batc...