Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

✍ Scribed by Feroz Jameel, Susan Hershenson

• Year: 2010
• Tongue: English
• Leaves: 986
• Edition: 1
• Category: Library

✦ Synopsis

A real-world guide to the production and manufacturing of biopharmaceuticalsWhile much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging.Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes:Research and early development phase–appropriate approaches for ensuring product stabilityDevelopment of commercially viable formulations for liquid and lyophilized dosage formsOptimal storage, packaging, and shipping methodsCase studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractionsUseful analysis of successful and failed productsFormulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

✦ Table of Contents

FORMULATION AND PROCESS DEVELOPMENT STRATEGIES FOR MANUFACTURING BIOPHARMACEUTICALS......Page 5
CONTENTS......Page 7
FOREWORD......Page 11
PREFACE......Page 15
CONTRIBUTORS......Page 19
PART I PREFORMULATION AND DEVELOPMENT OF STABILITY-INDICATING ASSAYS: BIOPHYSICAL CHARACTERIZATION TECHNIQUES......Page 23
1 THE STRUCTURE OF BIOLOGICAL THERAPEUTICS......Page 25
2 CHEMICAL INSTABILITY IN PEPTIDE AND PROTEIN PHARMACEUTICALS......Page 63
3 PHYSICAL STABILITY OF PROTEIN PHARMACEUTICALS......Page 91
4 IMMUNOGENICITY OF THERAPEUTIC PROTEINS......Page 127
5 PREFORMULATION RESEARCH: ASSESSING PROTEIN......Page 141
6 FORMULATION DEVELOPMENT OF PHASE 1–2 BIOPHARMACEUTICALS: AN EFFICIENT AND TIMELY APPROACH......Page 169
7 LATE-STAGE FORMULATION DEVELOPMENT AND CHARACTERIZATION OF BIOPHARMACEUTICALS......Page 183
8 AN EMPIRICAL PHASE DIAGRAM–HIGH-THROUGHPUT SCREENING APPROACH TO THE CHARACTERIZATION AND FORMULATION OF BIOPHARMACEUTICALS......Page 195
9 FLUORESCENCE AND PHOSPHORESCENCE METHODS TO PROBE PROTEIN STRUCTURE AND STABILITY IN ICE: THE CASE OF AZURIN......Page 229
10 APPLICATIONS OF SEDIMENTATION VELOCITY ANALYTICAL ULTRACENTRIFUGATION......Page 253
11 FIELD FLOW FRACTIONATION WITH MULTIANGLE LIGHT SCATTERING FOR MEASURING PARTICLE SIZE DISTRIBUTIONS OF VIRUS-LIKE PARTICLES......Page 275
12 LIGHT-SCATTERING TECHNIQUES AND THEIR APPLICATION TO FORMULATION AND AGGREGATION CONCERNS......Page 291
PART II DEVELOPMENT OF A FORMULATION FOR LIQUID DOSAGE FORM......Page 329
13 EFFECTIVE APPROACHES TO FORMULATION DEVELOPMENT OF BIOPHARMACEUTICALS......Page 331
14 PREDICTION OF AGGREGATION PROPENSITY FROM PRIMARY SEQUENCE INFORMATION......Page 351
15 HIGH-CONCENTRATION ANTIBODY FORMULATIONS......Page 371
16 DEVELOPMENT OF FORMULATIONS FOR THERAPEUTIC MONOCLONAL ANTIBODIES AND Fc FUSION PROTEINS......Page 405
17 REVERSIBLE SELF-ASSOCIATION OF PHARMACEUTICAL PROTEINS: CHARACTERIZATION AND CASE STUDIES......Page 451
PART III DEVELOPMENT OF A FORMULATION FOR LYOPHILIZED DOSAGE FORM......Page 479
18 DESIGN OF A FORMULATION FOR FREEZE DRYING......Page 481
19 PROTEIN CONFORMATION AND REACTIVITY IN AMORPHOUS SOLIDS......Page 515
20 THE IMPACT OF BUFFER ON SOLID-STATE PROPERTIES AND STABILITY OF FREEZE-DRIED DOSAGE FORMS......Page 529
21 STABILIZATION OF LYOPHILIZED PHARMACEUTICALS BY CONTROL OF MOLECULAR MOBILITY: IMPACT OF THERMAL HISTORY......Page 543
22 STRUCTURAL ANALYSIS OF PROTEINS IN DRIED MATRICES......Page 571
23 THE IMPACT OF FORMULATION AND DRYING PROCESSES ON THE CHARACTERISTICS AND PERFORMANCE OF BIOPHARMACEUTICAL POWDERS......Page 587
PART IV MANUFACTURING SCIENCES......Page 609
24 MANUFACTURING FUNDAMENTALS FOR BIOPHARMACEUTICALS......Page 611
25 PROTEIN STABILITY DURING BIOPROCESSING......Page 627
26 FREEZING AND THAWING OF PROTEIN SOLUTIONS......Page 647
27 STRATEGIES FOR BULK STORAGE AND SHIPMENT OF PROTEINS......Page 699
28 DRYING PROCESS METHODS FOR BIOPHARMACEUTICAL PRODUCTS: AN OVERVIEW......Page 727
29 SPRAY DRYING OF BIOPHARMACEUTICALS AND VACCINES......Page 761
30 DEVELOPMENT AND OPTIMIZATION OF THE FREEZE-DRYING PROCESSES......Page 785
31 CONSIDERATIONS FOR SUCCESSFUL LYOPHILIZATION PROCESS SCALE-UP, TECHNOLOGY TRANSFER, AND ROUTINE PRODUCTION......Page 819
32 PROCESS ROBUSTNESS IN FREEZE DRYING OF BIOPHARMACEUTICALS......Page 849
33 FILLING PROCESSES AND TECHNOLOGIES FOR LIQUID BIOPHARMACEUTICALS......Page 861
34 LEACHABLES AND EXTRACTABLES......Page 879
35 PRIMARY CONTAINER AND CLOSURE SELECTION FOR BIOPHARMACEUTICALS......Page 903
36 PREFILLED SYRINGES FOR BIOPHARMACEUTICALS......Page 919
37 IMPACT OF MANUFACTURING PROCESSES ON DRUG PRODUCT STABILITY AND QUALITY......Page 939
INDEX......Page 963