Quality Control Testing Throughout the Product Development Lifecycle (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: go.pda.org/BIOTECH

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Format: PDF (1 file 542 KB)

Table of Contents

Table of Contents:

  • Research and Development Programs
  • Early Stage Development
  • Late Stage Development
  • Commercial Testing
  • Selecting a Contract Testing Organization
  • Designing QC Testing Programs
  • Test Method Qualification vs. Test Method Validation
  • Test Method Qualification
  • Test Method Verification
  • Test Method Validation
  • Test Article Categories
  • Specialized Validation Testing
  • The Lifecycle of Contracted Testing Services
  • The Future of QC Laboratories
  • References

About the Authors

About the Authors

Dr. Daniel Prince is Chief Scientific Officer, Gibraltar Laboratories, Inc. (a Nelson Laboratories unit, located in Fairfield, NJ) and Chief Executive Officer, PRINCE Sterilization Services LLC, located in Pine Brook, NJ. Dr. Prince is an industrial expert in microbial control and anti-microbial claim substantiation. He is a passionate developer of talent and has an unwavering interest in the pursuit of excellence in all aspects of life.

Mr. Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. He has been at Nelson Laboratories for 25 years testing and consulting regarding radiation sterilization, bioburden/sterility testing, microbiological process validation, allograft tissue and pharmaceutical products. Mr. Winters serves on many AAMI Sterilization Standards Working Groups and represents the USA at ISO meetings for microbiological methods, aseptic processing and vaporized hydrogen peroxide sterilization. In 2018 he helped develop the program, and then certified as an AAMI Certified Industrial Sterilization Specialist in radiation (CISS-RAD).

Dr. Richard Prince is CEO, Now Biopharma, LLC. Now Biopharma is a boutique Clinical CRO (with a specialization in performing acute care trials) and a Life Science Consultancy (with expertise in helping start-up companies succeed). Dr. Prince has expertise in Life Science Entrepreneurship, C-level Management, Strategy, Scientific Affairs, Regulatory Affairs, Quality Operations, Clinical Development, and Operations Facilitation. Dr. Prince is also President and Partner, Pollination Ventures Management LLC, a management firm that evaluates and advises promising new life science startups on corporate structures and development.