Viral safety and evaluation of viral clearance from biopharmaceutical products : Natcher Conference Center, Bethesda, Maryland, USA, June 14-16, 1995
著者
書誌事項
Viral safety and evaluation of viral clearance from biopharmaceutical products : Natcher Conference Center, Bethesda, Maryland, USA, June 14-16, 1995
（Developments in biological standardization, v. 88）
Karger, 1996
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注記
"Proceedings of a symposium organized by the Food and Drug Administration (FDA), International Association of Biological Standardization (IABS), National Institute of Allergy and Infectious Dieseases (NIAID), U.S. Department of Agriculture (USDA), National Vaccine Program Office (NVPO)"--T.p
内容説明・目次
内容説明
Assurance that biopharmaceuticals do not contain unwanted infectious agents is a vital safety consideration in the use of these products. This can only be ensured by careful screening of the cells and other materials used in their production, and subsequent testing of the final product. This publication reports the proceedings of an international conference which focused on the methods of how to avoid contamination of cell cultures with virus during the production process of biologicals, with the aim of providing harmonized guidelines to ensure product safety. Scientists from industry and regulatory agencies present updates on the current state of knowledge about assays for viral contamination and procedures for inactivation and removal. Risks associated with the processing of biopharmaceuticals are identified, and data on the actual experiences of testing and industrial laboratories are presented and discussed in the context of the clinical setting. Drawing together a wealth of new data, this book will be essential reading for all scientists concerned with the development, production and quality control of biopharmaceutical products.
目次
- Session I: cell characterization
- session II: assay for screening contamination
- session III: evaluation of viral clearance
- session IV: manufacturing considerations
- session V: regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan
- breakout session A: sensitivity and specificity
- breakout session B: adventitious contaminants observed during characterization of QC testing - findings and follow-up
- breakout session C: adenoviral gene therapy issues
- breakout session D: lessons learned from related product categories
- breakout session E: adventitious agent screening assays
- breakout session F: adventitious agents from animal-derived raw materials and production systems
- breakout session G: retrovirus clearance for early clinical trials
- breakout session H: process evaluation
- summary and conclusion of the meeting.
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