Focusing on new 3D in vitro methods now available to researchers, this book brings together examples of leading-edge work being conducted internationally for improving in vitro cell culture methods, in particular the use of systems for enabling cell culture under laminar flow and the use of 3D scaffolds for providing cells with a structure which replicates the function of the extracellular matrix and encouraging interactions more akin to an in vivo environment.
John W. Haycockis director of the Centre for Biomaterials and Tissue Engineering and associate director of the Kroto Research Institute, University of Sheffield, UK. He has a PhD in neuroscience from Newcastle University, UK. His key areas of work include scaffolds for nerve injury repair, 3D nerve models as alternatives for animal testing, and 3D imaging. Prof. Haycock is a member of the EPSRC Peer Review College, UK, and internationally has served on grant-awarding panels and examination bodies in Canada (CFI), Finland, and Sweden.
Arti Ahluwalia is associate professor of bioengineering at the Department of Information Engineering, Faculty of Engineering; vice director of Interdepartmental Research Center "E. Piaggio"; and head of the MCB Group, University of Pisa, Italy. She is currently affiliated with National Council of Research Institute of Clinical Physiology (CNR-IFC), Italy, and is director of its NanoBioScopy Lab. Dr. Ahluwalia has a PhD in bioengineering from the Polytechnic of Milan, Italy. Her research is mainly centered on the interactions between biological systems and man-made materials devices or structures for the creation of organ and system models in vitro, tissue engineering, biosensing, robots for autism, bioreactors, and in vitromodels.
John M. Wilkinsonis the founder and managing director of Kirkstall Ltd., UK. Prior to founding Kirkstall, he had been managing a high-technology consulting company in Cambridge, UK, following a career in high-technology product development in both large corporations and startups. Dr. Wilkinson earned his PhD from Middlesex University, UK. He is a fellow of the Institute of Nanotechnology, UK, and has been a visiting lecturer for FSRM, Neuchatel, Switzerland, on the subject of micro- and nanotechnology in biomedical engineering for over ten years.
Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology:
Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs
A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market.
Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines:Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery
Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field.
By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.