Disposable Bioprocessing Systems: 1st Edition (Hardback) book cover

Disposable Bioprocessing Systems

1st Edition

By Sarfaraz K. Niazi

CRC Press

322 pages | 32 B/W Illus.

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Description

Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacturers are unwilling to discard investments made in fixed equipment and traditional stainless steel systems. Regulatory and environmental concerns, however, will eventually compel manufacturers to adopt disposable systems. Making a strong case for disposables, Disposable Bioprocessing Systems demonstrates the true potential of these systems.

Written by a researcher and professor with hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide, and creating model facilities using maximum disposable technology, this book is the first comprehensive introduction to understanding disposable systems. It gives an overview of the current state of the disposable bioprocessing industry, resolves all controversial issues, and guides readers in choosing disposable components that meet their needs. An important chapter on safety addresses facts and myths about the use of plastics and elastomers—including the issue of leaching—and how to ensure regulatory compliance.

Helping readers understand their choices, the book describes the equipment and systems available to prepare the starting materials for the manufacturing of biological drugs—from disposable containers to filters. The author also discusses costs, regulations, and concerns about waste disposal, and shares his predictions for the future of the disposable bioprocessing industry.

A practical manual for those interested in the transition to disposable systems, this book will also interest students of bioprocessing. It offers a timely view of disposable bioprocessing technology as a "game changer" that will facilitate developing new drugs and conducting research in the emerging field of stem cells and gene therapy.

Table of Contents

The Bioprocessing Industry—An Introduction

Summary

Appendix I: Complete Lines of Disposable Systems

Millipore Offers an Extensive Line (www.millipore.com)

Chromatography Columns

Safety of Disposable Systems

Polymers and Additives

Partnering with Vendors

Responsibility of Sponsors

Regulatory Requirements

Risk Assessment

Background

International Guidance and Standards

Containers

Proprietary Bag Suppliers

Generic Bag Suppliers

Tank Liners

2D Fluid Containers

2D Powder Bags

3D Bags

Transportation Container

Summary

Mixing Systems

Types of Mixing

Stirring Magnetic Mixer

Stirring Mechanical Coupling Mixer

Tumbling Mixer

Oscillating Mixer

Peristaltic Mixer

Summary

Disposable Bioreactors

Xcellerex Bioreactor

Cellexus Bioreactor

CELL-tainer Cell Culture System

Wave-Mixed Bioreactors

Stirred Single-Use Bioreactors

Integrity™ PadReactor™

CellReady Bioreactor

The Game Changers in Disposable Bioreactor Industry

Connectors and Transfers

Tubing

Fittings and Accessories

Pumps

Aseptic Coupling

Aseptic Connectors

Welding

Aseptic Transfer Systems

Tube Sealers

Sampling

Conclusion

Controls

Sampling Systems

TRACE System

Optical Sensors

Biomass Sensors

Electrochemical Sensors

Pressure Sensors

Conclusions

Downstream Processing

The Case of Monoclonal Antibodies: A GE Report

Membrane Chromatography

Virus Removal

Buffers

Fluid Management

Bioseparation

Depth Filtration

Ultrafiltration

Integrated Systems

Filling and Finishing Systems

Robert Bosch Packaging Systems

PDC Aseptic Filling Systems

Summary

Filtration

Dead-End Filtration

Cross-Flow Filtration

Filtration Media

Polymer Membranes

Microfiltration Cross-Flow

Conclusion

Regulatory Compliance

Regulatory Barriers

Irradiation and Sterilization Validation

Environmental Concerns

Biosafety

Liquid Waste

Incineration

Pyrolysis

Grind and Autoclave

Landfill

Treatment

Overall Environmental Impact

Summary

Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard

Appendix K: Physical Containment For Large-Scale Uses of Organisms Containing Recombinant DNA Molecules

Epilogue

Large Scale

Integrity

Flexibility

Universal Use

Scale-Up

Cost

Out of Steam

Validation

Leachables

Animal Origins

The Stainless Challenge

Standardization

Upstream

Compliance

High-Expression Cell Lines

Flexible Factories

Small Companies

Unitary Systems

Biosafety

Autoclaves

SIP/CIP

Distilled Water Loops

Low Ceiling Heights

Modular Systems

Gentle Mixing

2D Bags

Fluoropolymer Bags

Protein Capture

Downstream Processing

Closed Systems

Molecule-Specific Facilities

Max-Dispo Concept

Leachables/Extractables

Multipurpose Disposable Bioreactors

Bibliography

Index

About the Author

Sarfaraz K. Niazi has been teaching pharmaceutical sciences and conducting research in the field of drug and dosage form development for over 35 years. A former professor at the University of Illinois, Dr. Niazi has written over a hundred papers, dozens of books, and owns dozens of patents for his inventions in the field of drug development and biopharmaceutical processing, including patents on novel bioreactors. His first book on the subject, Handbook of Biogeneric Therapeutic Proteins (CRC Press), was widely received as a primer in the field of biological manufacturing. Niazi has hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide. He lives in Deerfield, Illinois.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED071000
MEDICAL / Pharmacology
SCI013060
SCIENCE / Chemistry / Industrial & Technical