Candice Johnson,Douglas Kiehl,Piet Christiaens et al.
Candice Johnson et al.
Leachables in pharmaceutical products may react with biomolecule active pharmaceutical ingredients (APIs), for example, monoclonal antibodies (mAb), peptides, and ribonucleic acids (RNA), potentially compromising product safety and efficacy...
Peer Schmidt,Martin J Lipa,Jace Fogle et al.
Peer Schmidt et al.
The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) Quality Risk Management To support ICH Q9(R1) understanding and adoption, this pape...
Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests [0.03%]
关于USP无菌产品微生物检查：微生物计数试验的意向使用说明的澄清通知
Edward C Tidswell,Radhakrishna S Tirumalai,Deborah D Gross
Edward C Tidswell
In the execution of its legislated responsibilities, the United States Food and Drug Administration commonly refers to standard test methods detailed in the United States Pharmacopeia (USP). Microbiological test methods (contained in genera...
Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry [0.03%]
生物制药行业中常见可见微粒的识别及原因分析
Bo Wang,Shanshan Zhang,Mengyi Chen et al.
Bo Wang et al.
Visible particle is an important issue in the biopharmaceutical industry, and it may occur across all the stages in the life cycle of biologics. Upon the occurrence of visible particles, it is often necessary to conduct chemical identificat...
Shanker Gupta
Shanker Gupta
Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug--Device Combination Products [0.03%]
口服吸入及鼻用药品及其他药械组合产品中有关生物相容性的考虑事项
Cheryl L M Stults,Christine L Lanning,Lee M Nagao et al.
Cheryl L M Stults et al.
Biocompatibility considerations have historically been important for orally inhaled and nasal drug products (OINDPs) and other drug-device combination products, because finished device components and packaging in these products are often in...
A Method to Investigate Sterilization Processes and the Bacterial Inactivation Resolved in Time and Space [0.03%]
一种研究灭菌过程及细菌失活的时间和空间解析方法
Manuel Feurhuber,Thomas Taupitz,Frank Mueller et al.
Manuel Feurhuber et al.
In this study, a computational fluid dynamics (CFD) model was developed to predict all relevant phenomena occurring during a moist heat sterilization process at a high level of temporal and spatial resolution. The developed CFD model was us...