Plasmid Biopharmaceuticals. Basics, Applications, and Manufacturing

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Over the last several years, manufacturers have expressed increasing interest in reducing their energy consumption and have begun to search for opportunities to reduce their energy usage. In this book, the authors explore a variety of opportunities to reduce the energy footprint of manufacturing. These opportunities cover the entire spatial scale of the manufacturing enterprise: from unit process-oriented approaches to enterprise-level strategies. Each chapter examines some aspect of this spatial scale, and discusses and describes the opportunities that exist at that level. Case studies demonstrate how the opportunity may be acted on with practical guidance on how to respond to these opportunities.

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Advanced manufacturing technologies (AMTs) combine novel manufacturing techniques and machines with the application of information technology, microelectronics and new organizational practices within the manufacturing sector. They include «hard» technologies such as rapid prototyping, and «soft» technologies such as scanned point cloud data manipulation. AMTs contribute significantly to medical and biomedical engineering. The number of applications is rapidly increasing, with many important new products now under development. Advanced Manufacturing Technology for Medical Applications outlines the state of the art in advanced manufacturing technology and points to the future development of this exciting field. Early chapters look at actual medical applications already employing AMT, and progress to how reverse engineering allows users to create system solutions to medical problems. The authors also investigate how hard and soft systems are used to create these solutions ready for building. Applications follow where models are created using a variety of different techniques to suit different medical problems One of the first texts to be dedicated to the use of rapid prototyping, reverse engineering and associated software for medical applications Ties together the two distinct disciplines of engineering and medicine Features contributions from experts who are recognised pioneers in the use of these technologies for medical applications Includes work carried out in both a research and a commercial capacity, with representatives from 3 companies that are established as world leaders in the field – Medical Modelling, Materialise, & Anatomics Covers a comprehensive range of medical applications, from dentistry and surgery to neurosurgery and prosthetic design Medical practitioners interested in implementing new advanced methods will find Advanced Manufacturing Technology for Medical Applications invaluable as will engineers developing applications for the medical industry. Academics and researchers also now have a vital resource at their disposal.

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

This book is the first of its kind to collectively address design-based and mechanical micro-manufacturing topics in one place. It focuses on design and materials selection, as well as the manufacturing of micro-products using mechanical-based micro-manufacturing process technologies. After addressing the fundamentals and non-metallic-based micro-manufacturing processes in the semiconductor industry, it goes on to address specific metallic-based micro-manufacturing processes, such as: micro-forming, micro-machining, micro-molding, micro-laser processing, micro-layered manufacturing, micro-joining, micro-assembly and materials handling, and microEDM and ECM. The book provides an in-depth understanding of materials behavior at micro-scales and under different micro-scale processing conditions, while also including a wide variety of emerging micro-scale manufacturing issues and examples.

This collection of high-profile contributions provides a unique insight into the development of novel, successful biopharmaceuticals. Outstanding authors, including Nobel laureate Robert Huber as well as prominent company researchers and CEOs, present valuable insider knowledge, limiting their scope to those procedures and developments with proven potential for the biotechnology industry. They cover all relevant aspects, from the establishment of biotechnology parks, the development of successful compounds and the implementation of efficient manufacturing processes, right up to the establishment of advanced delivery routes.

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine – from beginning to end – addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view – from facility design to manufacturing; and from a regulatory point of view – requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.