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...
Raw materials case histories [0.03%]
原料案例分析
Michael J Rubino
Michael J Rubino
This paper describes three case studies involving the handling of raw materials. One case study deals with animal-derived materials. The other two case studies demonstrate the need to also focus on raw materials with regard to recombinant b...
Bob Weaver,Scott Rosenthal
Bob Weaver
Adventitious viral contamination in mammalian cell culture manufacturing facilities can lead to loss of product due to regulatory concerns regarding potential health risks. These events can also result in manufacturing shutdowns for extende...
Gamma-irradiation of serum for the inactivation of adventitious contaminants [0.03%]
用γ射线辐照血清以灭活外来污染物
Gay Gauvin,Raymond Nims
Gay Gauvin
Assurance of viral and mycoplasma safety in biopharmaceuticals is best achieved through elimination of animal-derived materials from the manufacturing process. Where this is not possible, the risk of introducing a contaminant through use of...
Testing considerations for novel cell substrates: a regulatory perspective [0.03%]
新型细胞基质的检验考量：监管机构的观点
A S Khan
A S Khan
The development of new products for the prevention and treatment of current as well as emerging and re-emerging diseases has led to the introduction of novel cell substrates in biologics. Examples include the demand for large-scale producti...
The Avian EB66(R) Cell Line, Application to Vaccines, and Therapeutic Protein Production [0.03%]
EB66(R)禽用细胞系及其在疫苗和治疗性蛋白质生产中的应用
Stephen W Brown,Majid Mehtali
Stephen W Brown
Embryonated chicken eggs and primary chicken embryo fibroblasts (CEFs) have been used for decades as a means of manufacturing human and veterinary vaccines. However, these egg and CEF-based production systems are associated with many seriou...
Michael J Rubino
Michael J Rubino
The paper describes considerations taken with regard to a recombinant human cell line (HEK293) producing a therapeutic protein. When working with HEK293 cells, besides standard viral safety issues, special precautions should be taken becaus...
Application of lentiviral vectors for development of production cell lines and safety testing of lentiviral-derived cells or products [0.03%]
慢病毒载体在生产细胞系的开发及慢病毒来源细胞或产品安全性检测中的应用
Cherylene Plewa
Cherylene Plewa
Lentiviral vectors (LVs) are frequently used to engineer cell lines for preclinical research purposes including assay development and target validation. Development of production cell lines for manufacturing recombinant protein therapeutics...