Filtration and Purification in the Biopharmaceutical Industry

Summary

Expanded to include extensive new material on the critical role of purification and detailing the significant advances in filtration science and technology, this Second Edition of a classic reference provides stateof- the-science information on all aspects of filtration and purification, including current methods, processes, technologies, equipment, and the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.

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 Market: Filtration, Purification, Sterilization and Separation Scientists in The Pharmaceutical or Biotech Industries Working in Drug Development or Manufacturing
• Validation, Qa/Qc, and Compliance Professionals in The Pharmaceutical or Biotech Industries
• and Filtration, Purification, Sterilization, and Separation Product and Equipment Manufacturers