Quality by Design and Process Analytical Technology for Pharmaceutical Manufacturing in the 21st Century

By Stephen R. Byrn

Purdue University

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PAT or Process Analytical Technology is an initiative and guidance from the U.S. FDA to encourage modernization of pharmaceutical manufacturing. In reality, PAT is a subset of the larger concept of Quality by Design which is the implementation of design concepts for pharmaceutical dosage forms and processes to insure robust production of dosage forms with the desired performance attributes. A common misconception (partly due to the acronym) is that PAT refers to the monitoring technologies only. However, the primary goals of the PAT initiative are to encourage and facilitate three things:
  1. UNDERSTANDING of pharmaceutical manufacturing processes – i.e., quantitative models to predict the behavior of a process and identify what variables/parameters are critical.
  2. MONITORING these relevant process parameters in a timely manner – this must be in near real-time, however, there is NO requirement that it be prohibitively complicated or expensive. The relative sampling interval must simply be short compared to the overall processing time.
  3. CONTROLING your process – this is facilitated by the identification of critical points and monitoring techniques and is the only way to maintain high quality products (i.e., with desired performance attributes) and furthermore without control you don’t get PAT regulatory relief offered by the U.S. FDA for progressive sponsors.
This talk will summarize the state of the industry and science, offer an integrating strategy, discuss QbD in early development, and give an example of implementation of QbD-PAT concepts.


Stephen R. Byrn Dr. Stephen R. Byrn is the Charles B. Jordan Professor of Medicinal Chemistry in the School of Pharmacy at Purdue University in West Lafayette, Indiana. He is also Head of the Department of Industrial and Physical Pharmacy. Dr. Byrn received his B.A. degree in Chemistry from DePauw University and his Ph .D. degree in Chemistry from the University of Illinois, Urbana. He did postdoctoral research at UCLA. His research focuses on solid state chemistry, polymorphism, stability, manufacturing science, quality by design, and medicinal chemistry. Dr. Byrn opened up the field of solid state chemistry of drugs with his research and books of that title (first edition, 1982, second edition, 2000).

Dr. Byrn has founded/cofounded and directed several programs at Purdue University including CAMP, the Center for AIDS Research, the Molecules to Market program, and Purdue’s graduate programs in regulatory and quality compliance. He is also one of the founders and a member of the executive committee of NIPTE (National Institute for Pharmaceutical Technology and Education). He continues to be involved in educating scientists in solid state chemistry, methods of analysis, and regulatory science. Dr. Byrn has served as chair of the Pharmaceutical Sciences Advisory Committee to the FDA and Chair of the Drug Substances Technical Committee, Product Quality Research Initiative. Dr. Byrn has extensive experience as a consultant in the pharmaceutical industry and currently serves as Purdue’s representative to the USP.

Dr. Byrn is cofounder of SSCI, Inc. (Solid State Chemical Information) a cGMP research and information Company specializing in polymorphism, crystallization, analysis, problem solving and regulatory issues. SSCI, Inc. is now owned by Aptuit and Dr. Byrn serves as Head of the Aptuit Scientific Advisory Board. Dr. Byrn is also a technical founder of Andara now owned by Cyberkinetics, Inc. Andara specializes in devices and drugs for the treatment of spinal cord injury and CNS diseases.


Coauthor: Kenneth Morris, Ph. D.

Cite this work

Researchers should cite this work as follows:

  • Stephen R. Byrn (2008), "Quality by Design and Process Analytical Technology for Pharmaceutical Manufacturing in the 21st Century," http://nanohub.org/resources/5090.

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