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...
Integrating real-time viable biofluorescent particle counters within robotic gloveless isolators [0.03%]
在无指套隔离器中整合实时生物荧光颗粒计数器
Noel Long,Manny Khera,Bobby Lumia
Noel Long
Advanced technologies in both aseptic filling and environmental monitoring are coming together to improve the resilience and sterility assurance of aseptic processing. Continuous, real-time environmental monitoring using biofluorescent part...
Proactive replacement in aseptic manufacturing: A Health Index + Weibull/KaplanâMeier framework [0.03%]
无菌生产中的主动替换：健康指数+威布尔/ Kaplan-Meier框架
SaiVijay Thattukolla,SaiVinay Thattukolla
SaiVijay Thattukolla
Aseptic manufacturing depends on reliable equipment to maintain throughput and protect patients. This study presents a practical, reproducible maintenance engineering method for proactively replacing aging parts before failure; regulatory r...
Overcoming device component-related challenges and risks in prefilled syringe development [0.03%]
预填注射器开发中克服与部件相关的挑战和风险
Bettine Boltres,Fran deGrazio,Susan Neadle
Bettine Boltres
Developing medicines to serve patients is a complex, highly regulated process in which multiple interdependent factors must be aligned. If one aspect is not thoroughly evaluated, it may adversely affect others and ultimately the final produ...
The European Qualified Person: Legal Accountability, Quality Leadership, and AI Integration in Modern Pharmaceutical Manufacturing [0.03%]
欧洲合格人员：法律责任、质量领导力及现代制药生产中的人工智能整合
Mario Stassen
Mario Stassen
The European Qualified Person (QP) holds unique legal responsibility for certifying batch release, ensuring patient safety, and maintaining regulatory compliance. Modern pharmaceutical manufacturing-especially in biologics, ATMPs, and perso...
Development of Probabilistic Model to Predict Residual Seal Force of Crimped Vial Seals [0.03%]
预测安瓿瓶塞轧盖剩余密封力的概率模型的研究开发
DanaLouise Cabrita,George Currier,Anthony Petrella et al.
DanaLouise Cabrita et al.
One of the most important requirements for a sterile packaging system is container closure integrity (CCI). For vial-based systems comprised of a vial, a hyper-elastic stopper, and a rigid crimp seal, CCI testing is an integral part of the ...
Terra Kremer,Donald C Singer
Terra Kremer
Good contamination control practices in a controlled manufacturing environment demand consistency, which can be undermined by the common belief that the use of disinfectants alone will control the microbiological risk. This comes from a l...
PAT Implementation - Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products [0.03%]
PAT实施：从传统环境监测向无菌灌装产品的工艺过程中控的转变管理
Tony Cundell
Tony Cundell
Managing the transition from the new paradigm of in-process control using continuous biofluorescent particle counters from the traditional growth-based air monitoring is a difficult challenge requiring a comprehensive regulatory strategy. T...
Toni Manzano,William Whitford
Toni Manzano
This review article explores the application of artificial intelligence (AI) within Advanced Therapy Medicinal Products (ATMP) analysis, specifically focusing on challenges related to chemistry, manufacturing, and controls (CMC) and manufac...
Variability Assessment Methods for Lyophilized Drug Product, A Case Study [0.03%]
无菌冻干产品变异性评估方法之案例研究
Ajay Babu Pazhayattil,Marzena Ingram,Prasanna Sagar et al.
Ajay Babu Pazhayattil et al.
Lyophilization is a critical process, removing water and or solvent through sublimation to ensure the stability and longevity of injectable drug products. The complexity of the lyophilization process, involving multiple stages such as freez...