Manufacturing Biopharmaceuticals From Start-Up to Commercialization (single user digital version)

Feb 2020
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Building Value into Biotechnology Development and Manufacturing

The magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to Market, edited by Fred Mermelstein, Richard Prince and Carl Novina and offered electronically. These detailed advisories are written to provide guidance. Here is what Phillip A. Sharp, Ph.D and Nobel Laureate says about this text in his Foreword: "For anyone who wants to excel in biotechnology, this book presents a wonderful guide."

In addition to this reprint, there are more chapters in this comprehensive text that are equally informative in the areas of science, finance, legal and regulatory concerns. For a full text description, table of contents and purchasing details of this unique biotechnology guide and reference please visit:

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Format: PDF (1 file 607 KB)

Table of Contents

Table of Contents:

  • Introduction
  • Differences Between Drugs and Biologics
  • Process Design/Development (Recombinant Protein Biopharmaceuticals)
  • QTTP and Identification of CQAs and CPPs
  • Process Design and Process/Product Characterization for a Biopharmaceutical Product
  • Scale-up and Process Validation
  • Commercial Manufacturing
  • Cell Therapy, Gene Therapy and Personalized Medicines
  • References

About the Authors

About the Authors

Joseph Waggett has over 40 years of experience in the manufacturing and development of vaccines and biopharmaceuticals. He is currently President of Waggett & Associates where for the past 20 years he has worked with clients large and small around the globe to implement improved bioprocessing technology and state-of-the-art quality systems. He has worked for major pharmaceutical companies such as Glaxo SmithKline, Sanofi Pasteur and Pfizer overseeing the design and operation of numerous vaccine and large-scale cell culture biopharmaceutical manufacturing facilities.

Laura Grayson Roselli has 30 years of experience in biotechnology development, manufacturing, and education for leading pharmaceutical companies. She is a biopharmaceutical consultant whose industry experience includes GlaxoSmithKline, Wave Biotech and GE Healthcare. She currently serves as a Senior Adjunct Professor in Biology and Biotechnology programs at Rowan College of Burlington County. She has extensive experience in technical training, instructional design, course development, and resource coordination. She has developed web-based and traditional classroom and laboratory curricula for audiences ranging from middle school to college, professionals and community members.