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Filtration and Purification in the Biopharmaceutical Industry 3rd Edition by Maik Jornitz ISBN 9781351675680 1351675680

Original price was: $50.00.Current price is: $25.00.

Filtration and Purification in the Biopharmaceutical Industry Third Edition. Edition Jornitz Digital Instant Download

Author(s): Jornitz, Maik W.
ISBN(s): 9781315164953, 1315164957
Edition: Third edition.
File Details: PDF, 31.25 MB
Year: 2019
Language: English
SKU: EB-10429746 Category: Tags: ,

Filtration and Purification in the Biopharmaceutical Industry 3rd Edition by Maik Jornitz – Ebook PDF Instant Download/Delivery: 9781351675680 ,1351675680
Full download Filtration and Purification in the Biopharmaceutical Industry 3rd Edition after payment

Product details:
ISBN 10: 1351675680
ISBN 13: 9781351675680
Author: Maik Jornitz

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.

Filtration and Purification in the Biopharmaceutical Industry 3rd Edition Table of contents:

1. Prefiltration in Biopharmaceutical Processes

2. Charge-Modified Filter Media

3. Filter Designs

4. Membrane Pore Structure and Distribution

5. Filtrative Particle Removal

6. Microbiological Considerations in the Selection and Validation of Filter Sterilization

7. Filter Configuration Choices and Sizing Requirements

8. Stainless Steel Application and Fabrication in the Biotech Industry

9. Protein Adsorption on Membrane Filters

10. Integrity Testing

11. Filter Manufacturer’s Quality Assurance and Qualifications

12. Validation of the Filter and of the Filtration Process

13. Extractables and Leachables Evaluations for Filters

14. Media and Buffer Filtration Requirements

15. Downstream Processing

16. Ultrafiltration and Crossflow Microfiltration Filtration

17. Virological Safety of Biopharmaceuticals: How Safe Is Safe Enough?

18. A Rapid Method for Purifying Escherichia coli β-galactosidase Using Gel-Filtration Chromatography

19. Membrane Chromatography

20. Expanded Polytetrafluoroethylene Membranes and Their Applications

21. Gas Filtration Applications in the Pharmaceutical Industry

22. Sterility Testing by Filtration in the Pharmaceutical Industry

23. Bacterial Biofilms in Pharmaceutical Water Systems

24. Ozone Applications in Biotech and Pharmaceuticals

25. Disposable Equipment in Advanced Aseptic Technology

Index

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