- Language: English
- 776 Pages
- Published: March 2013
- Region: Global
Filtration and Purification in the Biopharmaceutical Industry. Edition No. 2. Drugs and the Pharmaceutical Sciences Part No. 174
- Published: November 2007
- Region: Global
- 816 Pages
- Informa Healthcare
Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, including the current methods, processes, technologies and equipment, and brings you up-to-date with the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.
An essential, comprehensive, source for all professionals involved with filtration and purification practices and compliance, this text
- addresses recent biotechnology-related processes and advanced technologies, such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and medium and buffer filtration
- presents detailed updates on the latest FDA and EMEA regulatory requirements involving filtration and purification practices
- describes current industry quality standards and validation requirements and provides guidance for compliance
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.
Maik J. Jornitz Sartorius North America Inc., Edgewood, New York, USA.
Theodore H. Meltzer Capitola Consulting Company, Bethesda, Maryland, USA.