Functionalization of chitosan/methylcellulose interpenetrating polymer network microspheres for gastroretentive application using central composite design [0.03%]
壳聚糖/甲基纤维素互穿网络微球的修饰及其在胃滞留给药系统中的应用
Pradeep Kumar,Meenakshi Bhatia
Pradeep Kumar
This study focuses on evaluation of the chitosan methylcellulose interpenetrating polymer network (CS/MC IPN) microspheres intended for mucoadhesive gastroretentive application and the optimization of formulation of cinnarizine-loaded CS/MC...
Implementation of Quality by Design (QbD) for Biopharmaceutical Products [0.03%]
基于质量的设计（QbD）在生物药品开发中的应用
Anurag Rathore
Anurag Rathore
Synthesis session [0.03%]
合成会议
Michael Wiebe,Kathryn King;Cell Substrate Task Force
Michael Wiebe
Regulatory expectations of validation/qualification of adventitious virus assays [0.03%]
监管部门关于外来病毒检验方法验证/确认的期望要求
S A Baylis,J Blümel
S A Baylis
The European Union (EU) guideline concerning the virus safety evaluation of biotechnological investigational medicinal products (CPMP/BWP/398498/2005) recently came into force. In the guideline it is stated that analytical procedures suppor...
Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period [0.03%]
十年来生物制药样本中意外病毒的检测
Andrew Kerr,Raymond Nims
Andrew Kerr
While viral safety is a major concern for biologics manufactured using mammalian cells, the numbers of viral contamination events reported in the literature are quite low. During a 10-year period during which biologics derived from a variet...
Apparent virus contamination in biopharmaceutical product at centocor [0.03%]
基因制药产品中出现病毒污染事件（Centocor公司）
Linda C Hendricks,Jarrat Jordan,Tong-Yuan Yang et al.
Linda C Hendricks et al.
Out-of-specification (OOS) results were reported by a contract lab in the in vitro adventitious agent assay (AVA) for two products manufactured using mouse myeloma cells in perfusion bioreactors. Cytopathic effect observed for test article-...
Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization [0.03%]
主细胞库(MCB)检定和特性描述过程中出现异常结果的原因调查
Dayue Chen,Christopher C Hatfield
Dayue Chen
We experienced two cases of unexpected results during master cell bank (MCB) testing and characterization at two individual testing companies over the last 5 years. Investigation was launched immediately upon receiving notice from the testi...
Rapid molecular assays for microbial contaminant monitoring in the bioprocess industry [0.03%]
生物工艺行业中微生物污染物监测的快速分子检测方法
Rangarajan Sampath,Lawrence B Blyn,David J Ecker
Rangarajan Sampath
Adventitious contaminations with bacterial, viral, or fungal infectious agents represent a major risk associated with the manufacture and release of pharmaceutical products for human use, including vaccines, protein-based therapeutics, and ...
A S Khan
A S Khan
Raw materials are critical components of product manufacture; these include source materials such as cell substrates, tissues, and biological fluids required for product manufacture, as well as biological materials required for cell growth,...
Raw materials in the manufacture of biotechnology products: regulatory considerations [0.03%]
生物技术产品原辅料的监管考量
Ruth Cordoba-Rodriguez
Ruth Cordoba-Rodriguez
The Food and Drug Administration's Pharmaceutical cGMPs for the 21st Century initiative emphasizes science and risk-based approaches in the manufacture of drugs. These approaches are reflected in the International Conference on Harmonizatio...