ABSTRACT

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.

chapter 1|20 pages

Prefiltration in Biopharmaceutical Processes

ByGeorge Quigley

chapter 2|20 pages

Charge-Modified Filter Media

ByEugene A. Ostreicher, Todd E. Arnold, Robert S. Conway

chapter 3|16 pages

Filter Designs

ByMaik W. Jornitz

chapter 4|16 pages

Membrane Pore Structure and Distribution

ByMaik W. Jornitz

chapter 5|58 pages

Filtrative Particle Removal

ByRoss Acucena

chapter 7|28 pages

Filter Configuration Choices and Sizing Requirements

ByMaik W. Jornitz

chapter 9|30 pages

Protein Adsorption on Membrane Filters

ByMaik W. Jornitz

chapter 10|56 pages

Integrity Testing

ByMagnus Andreas Stering

chapter 12|14 pages

Validation of the Filter and of the Filtration Process

ByPaul S. Stinavage

chapter 13|21 pages

Extractables and Leachables Evaluations for Filters

ByRaymond H. Colton, Denise G. Bestwick

chapter 14|18 pages

Media and Buffer Filtration Requirements

ByMaik W. Jornitz

chapter 15|34 pages

Downstream Processing

ByUwe Gottschalk

chapter 16|53 pages

Ultrafiltration and Crossflow Microfiltration Filtration

ByMichael Dosmar, Steven Pinto, Kirsten Jones Seymour

chapter 19|22 pages

Membrane Chromatography

BySherri Dolan, Susan Martin

chapter 20|16 pages

Expanded Polytetrafluoroethylene Membranes and Their Applications

ByMichael Wikol, Bryce Hartmann, Michael Debes, Cherish Robinson, Scott Ross, Uwe Beuscher

chapter 23|21 pages

Bacterial Biofilms in Pharmaceutical Water Systems

ByMarc W. Mittelman

chapter 24|18 pages

Ozone Applications in Biotech and Pharmaceuticals

ByJoseph Manfredi

chapter 25|12 pages

Disposable Equipment in Advanced Aseptic Technology

ByMaik W. Jornitz, Peter Makowenskyj