Innovation in the Biopharmaceutical Industry
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Innovation is at the heart of all advances and has the capacity to solve problems facing humanity. Societies which have turned away from innovation and technological development have failed in their ability to support their populations. Understanding the nature of innovation in the life sciences and in particular healthcare, how it operates, what enables and hinders it is therefore of great importance to meeting the challenges ahead. This book, originally and concurrently published in the International Journal of Innovation Management, Vol. 11, No. 2, 2007, offers the latest research and insights concerning innovation in the biopharmaceutical industry.
Single-Use Technology in Biopharmaceutical Manufacture
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This book gives an overview of commonly-used disposables in themanufacture of biopharmaceuticals, their working principles,characteristics, engineering aspects, economics, and applications.With this information, readers will be able to come to an easierdecision for or against disposable alternatives and to choose theappropriate system. The book is divided into two parts - thefirst is related to basic knowledge about disposable equipment; andthe second discusses applications through case studies thatillustrate manufacturing, quality assurance, and environmentalinfluence.
Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
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Sets forth tested and proven risk management practices indrug manufacturing Risk management is essential for safe and efficientpharmaceutical and biopharmaceutical manufacturing, control, anddistribution. With this book as their guide, readers involved inall facets of drug manufacturing have a single, expertly written,and organized resource to guide them through all facets of riskmanagement and analysis. It sets forth a solid foundation in riskmanagement concepts and then explains how these concepts areapplied to drug manufacturing. Risk Management Applications in Pharmaceutical andBiopharmaceutical Manufacturing features contributions fromleading international experts in risk management and drugmanufacturing. These contributions reflect the latest research,practices, and industry standards as well as the authors' firsthandexperience. Readers can turn to the book for: Basic foundation of risk management principles, practices, andapplications Tested and proven tools and methods for managing risk inpharmaceutical and biopharmaceutical product manufacturingprocesses Recent FDA guidelines, EU regulations, and internationalstandards governing the application of risk management to drugmanufacturing Case studies and detailed examples demonstrating the use andresults of applying risk management principles to drug productmanufacturing Bibliography and extensive references leading to the literatureand helpful resources in the field With its unique focus on the application of risk management tobiopharmaceutical and pharmaceutical manufacturing, this book is anessential resource for pharmaceutical and process engineers as wellas safety and compliance professionals involved in drugmanufacturing.
Pharmaceutical Biotechnology
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Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives--basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins and vaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens' genomes provides opportunities that never before have been available--identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated, replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process. The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies.