Piet Christiaens,Dennis Jenke,Jan Baeten et al.
Piet Christiaens et al.
Drug products and medical device extracts are chromatographically analysed via non-targeted analysis to detect, identify, and quantify organic leachables; GC/MS addresses primarily volatile and semi-volatile organic leachables. Identities o...
Digital Reference Materials: A New Standard for Quality and Compliance in Bio/Pharmaceutical Manufacturing [0.03%]
数字化参考标准品：生物/制药制造中质量与合规的新标准
Vadim Klyushnichenko
Vadim Klyushnichenko
As biopharmaceutical manufacturing evolves toward digitalization, the need for structured, interoperable, and regulatory-compliant data is intensifying. Digital Reference Materials (dRMs), the machine-readable counterparts of physical refer...
Charting the Universe of Organic Extractables and Leachables Compounds with Confirmed identities [0.03%]
绘制具有确认身份的有机可提取和浸出化合物宇宙图表
Dennis Jenke,Piet Christiaens,Adam Jenke et al.
Dennis Jenke et al.
Drug product leachables are substances that are leached from the drug products manufacturing system components during manufacturing operations, drug product packaging systems during storage over shelf-life, and delivery systems during admin...
NIIMBL-facilitated active listening meeting between industry and FDA identifies common challenges for adoption of alternative and rapid microbiological methods [0.03%]
NIIMBL促进的工业界与FDA之间的主动倾听会议识别了替代和快速微生物方法采用的共同挑战
Jennifer L Mantle,Eugene Schaefer,Kelvin H Lee
Jennifer L Mantle
Alternative and rapid microbiological methods (ARMM) used in biopharmaceutical manufacturing have potential advantages over current compendial methods in that they can enable faster product release and improved process monitoring and qualit...
Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies [0.03%]
关于非菌落计数的生物荧光颗粒计数技术验证的考量因素分析
Cynthia Martindale,Caroline Dreyer,Cedric Joossen et al.
Cynthia Martindale et al.
The use of Bio-Fluorescent Particle Counting technologies as a rapid, alternative method to monitor microbial contamination in water and cleanroom air samples has been of interest to the pharmaceutical industry for several years. These tech...
An Assessment of Pyrexia, Patient Age and Weight; Pediatric Considerations [0.03%]
评估发热、患者年龄和体重；儿科注意事项
Edward Charles Tidswell
Edward Charles Tidswell
Sterile drug products' endotoxin specifications are set in accordance with a compendial method that considers a patient population's body weight and the threshold pyrogenic dose for the particular route of administration (e.g. parenterally,...
Kite Pharma R&D Quality Internship: Poster Presented at PDA Week 2025 [0.03%]
凯特菲arma研发质量实习：PDA周2025会议海报展示
Devon B Cooper,Caitlin Fisher,Marjorie Stevenson
Devon B Cooper
The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key cont...
Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success: Poster Presented at PDA Week 2025 [0.03%]
持续过程验证计划的实施：用于市后合规性和产品成功（2025年PDA周壁报展示）
Anthony Stewart
Anthony Stewart
Continued Process Verification (CPV) is the third stage of the FDA Process Validation guideline and is a critical component of modern pharmaceutical manufacturing, ensuring that processes remain in a state of control throughout the product ...
Incorporating AI into the Process Validation Lifecycle: A Two-Way Street: Poster Presented at PDA Week 2025 [0.03%]
AI在过程验证生命周期中的应用：双向融合：PDA周2025会议壁报展示
Alyssa Burke
Alyssa Burke
Artificial intelligence (AI) continues to evolve and propel businesses forward; however, the Life Science industry's adoption of these technologies is delayed in comparison with other industries. AI technologies have the ability to greatly ...
Process Validation for Lyophilized Drug Products: Comparing a Program for Continued Process Verification in Different Lyophilized Products: Poster Presented at PDA Week 2025 [0.03%]
无菌药品冷冻干燥过程验证：比较不同冻干产品持续工艺确认项目：壁报展示（2025年PDA周会议）
Abirami Natesh,Denise Miller
Abirami Natesh
The 2011 FDA Guidance for Industry, "Process Validation: General Principles and Practices," emphasizes maintaining control of manufacturing processes throughout the product lifecycle through constant reevaluation. For lyophilized drug produ...