Statistics for Biotechnology Process Development

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.

Interpretation and Treatment of Data - Harry Yang, Steven J. Novick, and Lorin Roskos Design of Experiments (DOE) for Process Development -Todd Coffey Quality by Design Applied in Formulation Development and Robustness -Pierre Lebrun, Perceval Sondag, Xavier Lories, Jean-François Michiels, Eric Rozet, andBruno Boulanger Analytical Procedure Development and Qualification -Rick Burdick Strategic Bioassay Design, Development, Analysis, and Validation -David Lansky Setting Specifications -Harry Yang Statistical Analysis of Stability Studies -Laura Pack Continued Process Verification - Tara Scherder, Katherine Giacoletti Multivariate Analysis for Bioprocess Understanding and Troubleshooting - Jianchun Zhang and Harry Yang Assessment of analytical method robustness: statistical versus practical significance -Binbing Yu, Lingmin Zeng, and Harry Yang cGMP Sampling - Harry Yang

Todd Coffey (PhD Biostatistics) is the founding chair and an associate professor in the Department of Research and Biostatistics at the Idaho College of Osteopathic Medicine. Previously, he started a university-wide statistical consulting center at Washington State University and spend a decade in the biotechnology industry as a nonclinical statistician, making major contributions to successful worldwide regulatory submissions for multiple innovator biologics.