This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice.

It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations.

The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products.

This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

Provides step-by-step procedures, from idea to commercially viable biomedical product Guides readers through the good practice principles and regulations Highlights ethical aspects Offers insights into pre-clinical and clinical study design Serves as an indispensable guide for scientists and professionals in biomedical product development

Autorentext

Dr. Babak Arjmand, M.D., Ph.D. is the Head and Director of the Stem Cell and Regenerative Medicine Research Center at the Endocrinology and Metabolism Cellular-Molecular Sciences Institute, Tehran University of Medical Sciences in Iran. He graduated in Medicine from the Iran University of Medical Sciences (Tehran, Iran), and from 2011 to 2015 he completed his Ph.D. in Applied Cell Science at the Tehran University of Medical Sciences. His interests focus on developing cell and gene-based clinical products through translational pathways, from basic investigations to clinical research in line with GLP, GMP, and GCP standards. Dr. Arjmand has trained a large number of biomedical students and young researchers. He is the author of more than 100 articles published in scientific journals and has also published various books, book chapters and conference papers.Dr. Arjmand is the member of different scientific committees and societies such as, Tissue Engineering and Regenerative Medicine International Society (TERMIS), Asia Pacific Association of Surgical Tissue Banks (APASTB), Iranian Tissue Engineering and Regenerative Medicine (ITERM), National Committee of Tissue, Cell and Gene Therapy at Iran Food and Drug Administration (Iran-FDA), Iranian Council of Stem Cell Technologies, and National Working Group for Providing National Guideline on Stem Cell therapy.  Dr. Moloud Payab obtained her B.Sc. and M.S. in Nutrition Sciences from Tehran Islamic Azad University in 2007 and Tehran University of Medical Sciences in 2011, respectively. She then completed her Ph.D. at the Obesity and Eating Habits Research Center, at the Endocrinology and Metabolism Clinical Sciences Institute (EMRI), which is affiliated to Tehran University of Medical Sciences. She has worked as a researcher at EMRI since 2012. To date, Dr. Payab's research has mostly been in the field of clinical and population studies from an endocrinology perspective, including but not limited to obesity. Further, she has been actively involved in designing, planning, implementing and monitoring several basic and clinical research projects. Her particular interest is cell therapy in the field of obesity using various cell-based products, and she closely collaborates with the Cell Therapy and Regenerative Medicine Research Center at EMRI.
Dr. Parisa Goodarzi obtained her B.Sc. in Nursing at Tehran University of Medical Sciences Iran in 1996. Then, she completed her M.S. in Geriatric Nursing at Iran University of Medical Sciences, Tehran, Iran in 2016. Since 2008, Parisa Goodarzi has worked as a researcher at Tehran University of Medical Sciences. She has extensive experience in the implementation of quality management systems (QMS) in the field of cell and tissue-based products and product development pathways. She is also the author of more than 50 articles that have been published in scientific journals, books and conference proceedings.

Inhalt

1. An Introduction to Biomedical Product Development.- 2. Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences.- 3. Principles of Good Laboratory Practice (GLP).- 4. Design of Experimental Studies in Biomedical Sciences.- 5. Preclinical Studies for Development of Biomedical Products.- 6. Principles of Good Manufacturing Practice (GMP).- 7.The importance of Cleanroom facility in manufacturing of biomedical products.- 8. Safety concerns and requirement of cell based products for clinical application.- 9. Standards and regulatory frameworks (for cell and tissue based products).- 10. Principles of Good clinical Practice (GCP).- 11. Design, performance and monitoring of clinical trials.- 12. Good Clinical Practice: Guidelines and Requirement.- 13. Ethical Considerations of Biomedical Products Development.