Filtration and Purification in the Biopharmaceutical Industry, Second edition has been 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 state-of-the-science information on all aspects of filtration and purification, including:

• current methods
• processes
• technologies
• equipment
• the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries

Contents

1. Depth and Lenticular Filtration
2. Prefiltration
3. Charge-Modified Filter Media
4. Filter Designs
5. Quality Assurance of Filter Manufacture
6. Pore Size and Distributions
7. Extractables and Compatibilities of Filters
8. Bacterial Biofilms
9. Filtrative Particle Removal
10. Integrity Testing
11. Sizing of Membrane Filter Systems
12. Filter Housings
13. Cross-Flow Filtration
14. Protein Adsorption on Membrane Filters
15. Microbial Retention Testing
16. Filtration of Viral Contamination
17. Membrane Chromatography
18. LAL Testing
19. Air Filtration in the Biopharmaceutical Industry
20. Sterility Testing with Membrane Filters
21. Cell Harvesting
22. Downstream Processing
23. Important Factors in Media and Buffer Filtration
24. The Filtration of Blood and Blood Fractions
25. The Operation of the FDA
26. The Operation of the EMEA
27. Validation of Particle Counters
28. Validation of Filtrative Sterilization

Index

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