Separations Technology: Pharmaceutical and Biotechnology Applications, 1st Edition (Hardback) book cover

Separations Technology

Pharmaceutical and Biotechnology Applications, 1st Edition

Edited by Wayne P. Olson

CRC Press

576 pages

Purchasing Options:$ = USD
Hardback: 9780935184723
pub: 1995-06-01
$210.00
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Description

Authored by a team of respected scientists and technologists, this book covers many pharmaceutical and biotechnology separations methods currently in use. Practical applications and descriptions are offered for air elutriation, microporous filtration, ultrafiltration, phase partitioning, crystallization, and chromatographic technologies such as adsorption, affinity, chelate, ion-exchange, size-exclusion, template, hydrophobic interaction, biotransformations, and chiral separations.

Containing hundreds of references and a complete index, this book is designed for research and development scientists, process optimization engineers, and quality control laboratory scientists as well as quality assurance professionals and others needing to understand current separation techniques.

Table of Contents

Separations in Pharmaceutical Manufacturing, Wayne P. Olson

Pure Drugs v. Crude Preparations: Conventional Pharmaceuticals v. Folk Medicine

Developing a Drug (Apart from Regulatory Issues)

Sizing a Chromatographic System

Purification Methods

Purification Steps and Yield

Isolators

Scaleup from a Published Bench Method

Automation

References

Membrane Pervaporation, Timothy deVilliers Naylor

Principles of Pervaporation

Factors Affecting Membrane Performance

Energy Requirements

Application Opportunities

Conclusions

References

Tangential Flow Filtration, Stephen L. Michaels, et al.

The History of Tangential Flow Filtration

Principles and Theory

Tangential Flow Filtration Equipment

Application Classes in Pharmaceutical Separations

Principles of Tangential Flow Filtration Maintenance

Principles of Tangential Flow Filtration Validation and Qualification

References

Recommended Reading

Supercritical Fluid Extraction/Chromatography

Kent M. Payne, Jerry W. King

Theory

Applications of Supercritical Fluids

Supercritical Process Equipments

Conclusion

References

Preparative Separation of Enantiomers, Charles M. Grill, John R. Kern, Scott R. Perrin

Practical Aspects

Optimization Strategy

Preparative Chromatographic Resolution of the µ-Burke Olefin

Resolution of Racemates by Closed Loop Recycling Chromatography

Continuous Preparative Techniques for Resolving Racemic Mixtures

New Techniques

References

Chromatographic Purification of Recombinant Protein Products, Eugene P. Kroeff

Purification Challenges

System Selectivity

Process Reproducibility

Process Scaleup Considerations

Examples of Chromatographic Purification of rDNA Products

Summary

References

Affinity Chromatography, Wayne P. Olson

Definitions

Origins of Affinity Separations

Affinity Pairs: Examples

Matrices of Choice

Ligand Immobilization Chemistries

Elution Strategies

Analysis of the Products

References

Monoclonal Antibodies, Gary Christiansen

Definitions

Historical Notes

The Production of Monoclonal Antibodies

Purification Objectives and Goals

Purification Methods

Recent Advances and Future Trends

Conclusions

References

Immunoaffinity Purification of Proteins for Injection, and the Issue of Animal Viruses, Wayne P. Olson

Immobilized Antigens and Antibodies - A Research Tool

Immunosorbents for the Purification of Human Clotting Factor VIII for Injection

The Issue of Virus Elimination and/or Destruction

Preferred Methods for Antibody Immobilization

Scaling from the Limiting Step in Process

Charging and Eluting the Column

Issues with Immobilized Antibodies

Automation of the Cycle

Cell Purification with Immobilized Antibodies

Comparison of Immunosorbent with Other Methods

References

Process Validation of Separation Systems, Steven S. Kuwahara, Jane H. Chuan

Types of Validation

Why Validate?

Who, What, and Where to Conduct Validations

Extent of Validations

General Considerations

Getting Started: What Needs to Be in Place Before Beginning Your Validation

Separation Systems

References

A Salute to the Human Plasma Processing Industry and Its Founders, E.J. Cohn et al., Robert Tenold

Fractionation Automation

Centrifuges

Filters and Process Filter Media

Wiped or Thin Film Evaporation Systems

Screen Systems

Ultrafiltration/Diafiltration

Gel Chromatography

Lyophilization

Putting Out Fires

Acknowledgments

References

Index

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General