ABSTRACT

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.

chapter 6|24 pages

Setting Specification

chapter 11|22 pages

cGMP Sampling