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Full Description
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.
Features:
Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
It discusses the advantages of single-use process technologies and the qualification needs
Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Contents
Depth and Lenticular Filtration
Prefiltration
Charge-Modified Filter Media
Filter Designs
Quality Assurance of Filter Manufacture
Pore Size and Distributions
Extractables and Compatibilities of Filters
Bacterial Biofilms
Filtrative Particle Removal
Integrity Testing
Sizing of Membrane Filter Systems
Filter Housings
Cross-Flow Filtration
Protein Adsorption on Membrane Filters
Microbial Retention Testing
Filtration of Viral Contamination
Membrane Chromatography
LAL Testing
Air Filtration in the Biopharmaceutical Industry
Sterility Testing with Membrane Filters
Cell Harvesting
Downstream Processing
Important Factors in Media and Buffer Filtration
The Filtration of Blood and Blood Fractions
The Operation of the FDA
The Operation of the EMEA
Validation of Particle Counters
Validation of Filtrative Sterilization
