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.
Table of Contents
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, and Bruno 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.