Validation of Biopharmaceutical Manufacturing

The first complete one-volume reference on the topic, this book describes all aspects of process validation in the licensure of recombinant biologics, for both protein and non-protein products. It covers product synthesis, purification, and filling/finishing.

Preface

ix

1. Historical, Current, and Future Trends for Validating Biological Processes

1

(11)

R. Andrew Ramelmeier

Brian D. Kelley

Christi Van Horn

2. Process Characterization Studies To Facilitate Validation of a Recombinant Protein Fermentation

12

(16)

Jinyou Zhang

Jay Reddy

Peter Salmon

Barry Buckland

Randy Greasham

3. Validation of Continuously Perfused Cell Culture Processes for Production of Monoclonal Antibodies

28

(16)

S.C. Whitaker

R. Francis

R.C. Siegel

4. Establishment of Proven Acceptable Process Control Ranges for Production of a Monoclonal Antibody by Cultures of Recombinant CHO Cells

44

(11)

Robert G. Gerber

Paul R. McAllister

Carol A. Smith

Thomas M. Smith

Dane W. Zabriskie

Alan R. Gardner

5. Validation of the Recombinant Coagulation Factor IX Purification Process for the Removal of Host Cell DNA

55

(14)

M.W. Leonard

L. Sefton

R. Costigan

L. Shi

B. Hubbard

D. Bonam

B.D. Kelley

B. Foster

T. Charlebois

6. Worst-Case Approach To Validation of Operating Ranges

69

(11)

Alan R. Gardner

Thomas M. Smith

Robert G. Gerber

Dane W. Zabriskie

7. Establishment of Operating Ranges in a Purification Process for a Monoclonal Antibody

80

(13)

Thomas M. Smith

Eileen Wilson

Robert G. Scott

John W. Misczak

John M. Bodek

Dane W. Zabriskie

8. Robustness Testing of a Chromatographic Purification Step Used in Recombinant Factor IX Manufacture

93

(21)

Brian D. Kelley

Lei Shi

Duane Bonam

Brian Hubbard

9. Virus Removal and Inactivation: A Decade of Validation Studies: Critical Evaluation of the Data Set

114

(11)

Joachim K. Walter

Franz Nothelfer

William Werz

10. Reuse Validation of an Anion Exchange Chromatography Step for Purification of Clinical-Grade Ciliary Neurotrophic Factor

125

(19)

Somesh Nigam

Gary Ruezinsky

James Dugger

11. Start-Up and Validation of Sterile Formulation and Filling Processes for the Manufacture of Parenteral Aluminum Hydroxide-Based Vaccines

144

(26)

R.A. Ramelmeier

P.M. McHugh

M.S. Rienstra

C.J. Orella

W.L. Stobart

M.W. Henley

R.D. Sitrin

12. Changes in Biologics Regulations: Impact on the Development and Validation of the Manufacturing Processes for Well-Characterized Products

170

(13)

Kimberlee K. Wallace

Antonio R. Moreira

Author Index

183

(2)

Subject Index

185

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Validation of Biopharmaceutical Manufacturing Processes

Summary

Table of Contents

Supplemental Materials