Fundamentals of Biologicals Regulation - Couverture souple

Sheets

Couverture souple

ISBN 10 : 0443219885 ISBN 13 : 9780443219887

Editeur : Academic Press, 2026

Synopsis

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. The book provides in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes.

This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.

A propos du livre

À propos des auteurs

Dr. Rebecca Sheets is currently the Vice President for the International Alliance of Biologicals Standardization, North American affiliate. She is the former Vaccine Scientific and Regulatory Specialist at the National Institute of Allergy and Infectious Diseases. Dr. Sheets served 9 years as a Scientific Reviewer in the Viral Vaccines branch of the Division of Vaccines and Related Products Applications at the Center for Biologics Evaluation and Research at the FDA. From 2006-2014, she served as Co-Chair of the World Health Organization's Study Group on Cell Substrates and as Chair of the Adventitious Agents Sub-committee, as well as authoring several WHO guidelines and publications over the past two decades. She also taught for a decade at the Catholic University of America. Before retirement, she was the Principal Consultant at Grimalkin Partners from 2013-2021.

Dr. Kathryn C. Zoon is a U.S.-based immunologist, elected to the U.S. Institute of Medicine in 2002 for her research on human interferons and administrative public health contributions. She is the former scientific director of the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) in Bethesda, Maryland (2006-2015). From 1992 to 2002, Dr. Zoon was director of the FDA Center for Biologics Evaluation and Research (CBER). She is currently Scientist Emerita, NIH and on the Board of Directors of Emergent Biosolutions, Inc. and the International Biomedical Research Alliance. Dr. Zoon obtained her B.S. cum laude from Rensselaer Polytechnic Institute in 1970 and her Ph.D. in biochemistry from Johns Hopkins University in 1976. Soon after receiving her Ph.D., she undertook a training fellowship in the NIH laboratory of Christian B. Anfinsen, who had won the 1972 Nobel Prize in Chemistry.

Dr. Mark Schenerman is currently Graduate Program Director and Professor of the Practice of Biotechnology at UMBC. He is also President of a consulting firm (CMC Biotech-MAS Consulting) that he founded and is advising academic, industry, and regulatory agency groups. He is an experienced biopharmaceutical scientist and executive (over 25 years) who was responsible for leading cross-functional Chemistry, Manufacturing, & Control (CMC) strategy and teams at Novavax and MedImmune/AstraZeneca. Dr. Schenerman headed an R&D group at MedImmune/AstraZeneca that performed structural and biological characterization of preclinical and clinical products, stability and release testing, technology transfer to quality control and ongoing product development support. Since joining MedImmune in 1994, Dr. Schenerman played an integral role in developing and leading the company's Analytical Biochemistry function, supporting all stages of product development. Prior to joining MedImmune, Dr. Schenerman held positions in biologics development and research and development at Bristol-Myers Squibb Company and was a post-doctoral fellow at Cornell University. He earned his Bachelor's degree in Medical Technology at the University of Maryland and his doctorate in Biochemistry and Molecular Biology at the University of Florida.

Dr. Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Neadle's leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA's 2021 Awards for Regulatory Affairs Excellence. Neadle retired from a distinguished and impactful 26-year career at Johnson & Johnson. She is now Principal Consultant at Combination Products Consulting Services LLC, providing international Q&C, regulatory and design excellence services, to the pharm, biotech and device industries. Neadle serves as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International, AAMI and PQRI. She teaches curricula in Combination Products through UMBC and AAMI, as well as customized training upon request.

Christopher Hamlin is Senior Manager of Regulatory Affairs - CMC at PCI Pharma Services, where he leads a Regulatory Affairs team supporting manufacturing sites across the United States and in Europe. Prior to joining PCI, he was an employee at Division of AIDS at the National Institute of Allergy and Infectious Disease with the U.S. National Institute of Health (DAIDS/NIAID/NIH) where he contributed to the development and translation of HIV vaccine candidates into clinical trials. He was with the Walter Reed Army Institute of Research (WRAIR) and participated in the U.S. Military's HIV Research Program in the Laboratory of Antigen and Adjuvant Research where his protein characterization work contributed to multiple scientific publications. He holds a Master of Science degree in Biotechnology from the Catholic University of America in Washington, DC and Bachelor of Science in Biochemistry Marietta College in Marietta, OH.

Détails de l'édition

• Éditeur: Academic Press
• Date d'édition: 2026
• Langue: anglais
• ISBN 10: 0443219885
• ISBN 13: 9780443219887
• Reliure: Broché
• Numéro d'édition: 2
• Nombre de pages: 616
• Coordonnées du fabricant: Academic Press; https://shop.elsevier.com/; ; 230 PARK AVENUE, SUITE 800; NY; NY; 10169; Etats-Unis
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