G. V. Reklaitis

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Herausgeber: Reklaitis, Gintaras V; García-Munoz, Salvador; Seymour, Christine

• Gebundenes Buch

Produktbeschreibung

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.

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Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 416
• Erscheinungstermin: 9. Oktober 2017
• Englisch
• Abmessung: 234mm x 159mm x 28mm
• Gewicht: 666g
• ISBN-13: 9780470942376
• ISBN-10: 0470942371
• Artikelnr.: 33868129

Autorenporträt

GINTARAS.V. REKLAITIS, PhD, is Professor of Chemical Engineering and Industrial & Physical Pharmacy at Purdue University, member of the U.S. National Academy of Engineering, and the Deputy Director of the NSF Engineering Research Center on Structured Organic Particulate Systems. CHRISTINE SEYMOUR, PhD, is Director in Global Regulatory Chemistry, Manufacturing & Controls at Pfizer Inc, the 2018 President of AIChE, and a Director in AIChE's Society for Biological Engineering. SALVADOR GARCÍA-MUNOZ, PhD, is a Senior Engineering Advisor in Process Modeling and Optimization in Small Molecule Development at Eli Lilly and Company.

Inhaltsangabe

List of Contributors xiii Preface xix 1 Introduction 1 Christine Seymour
and Gintaras V. Reklaitis 1.1 Quality by Design Overview 1 1.2
Pharmaceutical Industry 2 1.3 Quality by Design Details 3 1.4 Chapter
Summaries 4 References 7 2 An Overview of the Role of Mathematical Models
in Implementation of Quality by Design Paradigm for Drug Development and
Manufacture 9 Sharmista Chatterjee, Christine M. V. Moore, and Moheb M.
Nasr 2.1 Introduction 9 2.2 Overview of Models 9 2.3 Role of Models in QbD
12 2.4 General Scientific Considerations for Model Development 20 2.5
Scientific Considerations for Maintenance of Models 22 2.6 Conclusion 23
References 23 3 Role of Automatic Process Control in Quality by Design 25
Mo Jiang, Nicholas C. S. Kee, Xing Yi Woo, Li May Goh, Joshua D. Tice,
Lifang Zhou, Reginald B. H. Tan, Charles F. Zukoski, Mitsuko Fujiwara,
Zoltan K. Nagy, Paul J. A. Kenis, and Richard D. Braatz 3.1 Introduction 25
3.2 Design of Robust Control Strategies 31 3.3 Some Example Applications of
Automatic Feedback Control 35 3.4 The Role of Kinetics Modeling 40 3.5
Ideas for a Deeper QbD Approach 42 3.6 Summary 44 Acknowledgments 46
References 47 4 Predictive Distributions for Constructing the ICH Q8 Design
Space 55 John J. Peterson, Mohammad Yahyah, Kevin Lief, and Neil Hodnett
4.1 Introduction 55 4.2 Overlapping Means Approach 56 4.3 Predictive
Distribution Approach 59 4.4 Examples 61 4.5 Summary and Discussion 68
Acknowledgments 69 References 69 5 Design of Novel Integrated
Pharmaceutical Processes: A Model?]Based Approach 71 Alicia
Román?]Martínez, John M. Woodley, and Rafiqul Gani 5.1 Introduction 71 5.2
Problem Description 73 5.3 Methodology 76 5.4 Application: Case Study 80
5.5 Conclusions 91 References 91 6 Methods and Tools for Design Space
Identification in Pharmaceutical Development 95 Fani Boukouvala, Fernando
J. Muzzio, and Marianthi G. Ierapetritou 6.1 Introduction 95 6.2 Design
Space: A Multidisciplinary Concept 98 6.3 Integration of Design Space and
Control Strategy 102 6.4 Case Studies 102 6.5 Conclusions 119
Acknowledgment 120 References 120 7 Using Quality by Design Principles as a
Guide for Designing a Process Control Strategy 125 Christopher L. Burcham,
Mark LaPack, Joseph R. Martinelli, and Neil McCracken 7.1 Introduction 125
7.2 Chemical Sequence, Impurity Formation, and Control Strategy 130 7.3
Mass Transfer and Reaction Kinetics 140 7.4 Optimal Processing Conditions
165 7.5 Predicted Product Quality under Varied Processing Conditions 174
7.6 Conclusions 186 Acknowledgments 187 Notation 187 Acronyms 187 Symbols
187 Notes 189 References 189 8 A Strategy for Tablet Active Film Coating
Formulation Development Using a Content Uniformity Model and Quality by
Design Principles 193 Wei Chen, Jennifer Wang, Divyakant Desai, Shih?]Ying
Chang, San Kiang, and Olav Lyngberg 8.1 Introduction 193 8.2 Content
Uniformity Model Development 197 8.3 RSD Model Validation and Sensitivity
Analysis for Model Parameters 212 8.4 Model?]Based Design Space
Establishment for Tablet Active Film Coating 219 8.5 Summary 229 Notations
230 References 230 9 Quality by Design: Process Trajectory Development for
a Dynamic Pharmaceutical Coprecipitation Process Based on an Integrated
Real?]Time Process Monitoring Strategy 235 Huiquan Wu and Mansoor A. Khan
9.1 Introduction 235 9.2 Experimental 237 9.3 Data Analysis Methods 239 9.4
Results and Discussion 240 9.5 Challenges and Opportunities for PCA?]Based
Data Analysis and Modeling in Pharmaceutical PAT and QbD Development 250
9.6 Conclusions 252 Acknowledgments 252 References 253 10 Application of
Advanced Simulation Tools for Establishing Process Design Spaces Within the
Quality by Design Framework 257 Siegfried Adam, Daniele Suzzi, Gregor
Toschkoff, and Johannes G. Khinast 10.1 Introduction 257 10.2 Computer
Simulation?]Based Process Characterization of a Pharmaceutical Blending
Process 261 10.3 Characterization of a Tablet Coating Process via CFD
Simulations 276 10.4 Overall Conclusions 294 References 295 11 Design Space
Definition: A Case Study--Small Molecule Lyophilized Parenteral 301 Linas
Mockus, David LeBlond, Gintaras V. Reklaitis, Prabir K. Basu, Tim Paul,
Nathan Pease, Steven L. Nail, and Mansoor A. Khan 11.1 Introduction 301
11.2 Case Study: Bayesian Treatment of Design Space for a Lyophilized Small
Molecule Parenteral 302 11.3 Results 307 11.4 Conclusions 311 Appendix 11.A
Implementation Using WinBUGS and R 311 Shelf Life 315 Notation 316
Acknowledgments 317 References 317 12 Enhanced Process Design and Control
of a Multiple?]Input Multiple?]Output Granulation Process 319 Rohit
Ramachandran 12.1 Introduction and Objectives 319 12.2 Population Balance
Model 320 12.3 Simulation and Controllability Studies 323 12.4
Identification of Existing "Optimal" Control?]Loop Pairings 327 12.5 Novel
Process Design 330 12.6 Conclusions 335 References 336 13 A Perspective on
the Implementation of QbD on Manufacturing through Control System: The
Fluidized Bed Dryer Control with MPC and NIR Spectroscopy Case 339 Leonel
Quiñones, Luis Obregón, and Carlos Velázquez 13.1 Introduction 339 13.2
Theory 340 13.3 Materials and Methods 344 13.4 Results and Discussion 348
13.5 Continuous Fluidized Bed Drying 355 13.6 Control Limitations 356 13.7
Conclusions 357 Acknowledgment 357 References 357 14 Knowledge Management
in Support of QbD 361 G. Joglekar, Gintaras V. Reklaitis, A. Giridhar, and
Linas Mockus 14.1 Introduction 361 14.2 Knowledge Hierarchy 363 14.3 Review
of Existing Software 364 14.4 Workflow?]Based Framework 365 14.5 Drug
Substance Case Study 368 14.6 Design Space 374 14.7 Technical Challenges
382 14.8 Conclusions 384 References 385 Index 387