development and manufacture of protein pharmaceuticals pharmaceutical biotechnology

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Development And Manufacture Of Protein Pharmaceuticals

Author : Steve L. Nail
ISBN : 9781461505495
Genre : Medical
File Size : 25. 62 MB
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In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.

Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

Author : Feroz Jameel
ISBN : 9780470118122
Genre : Science
File Size : 81. 85 MB
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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.

Handbook Of Pharmaceutical Biotechnology

Author : Shayne Cox Gad
ISBN : 0470117109
Genre : Medical
File Size : 56. 62 MB
Format : PDF
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A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.

Gibaldi S Drug Delivery Systems In Pharmaceutical Care

Author : Mary Lee
ISBN : 9781585281367
Genre : Medical
File Size : 86. 49 MB
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It is important to make therapeutics a critical component of teaching about dosage forms and to make dosage forms and drug delivery systems an integral part of therapeutics. This book will be the first to focus on the therapeutic impact of drug dosage forms.Tying together concepts of traditional pharmaceutics with therapeutics, Drug Delivery Systemsin Pharmaceutical Care demonstrates how the modern clinical pharmacist can integrate knowledge in pharmaceutical sciences and therapeutics with appreciation of patient needs and nuances to advise on preferable and optimal product choices.Each chapter represents a collaboration of a clinical pharmacist practitioner and a pharmaceutical scientist. This unique perspective takes the science of dosage form design and helps translate the theory into the pragmatic.Special Features: Case studies and problems to help students get a better understanding of concepts Well-organized chapters with outlines and objectives Summary tables and helpful figures, along with reasonable compilations of original references Final sections with 'Learning Points' that reinforce essential material. Foreword by William J. Jusko, PhD, Professor and Chair, University of Buffalo, Department of Pharmaceutical Sciences

Biotechnology And Biopharmaceutical Manufacturing Processing And Preservation

Author : Kenneth E. Avis
ISBN : 1574910167
Genre : Medical
File Size : 45. 14 MB
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In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.

Pharmaceutical Biotechnology

Author : Gary Walsh
ISBN : 9781118685754
Genre : Science
File Size : 89. 91 MB
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Pharmaceutical Biotechnology offers students taking Pharmacyand related Medical and Pharmaceutical courses a comprehensiveintroduction to the fast-moving area of biopharmaceuticals. With aparticular focus on the subject taken from a pharmaceuticalperspective, initial chapters offer a broad introduction to proteinscience and recombinant DNA technology- key areas that underpin thewhole subject. Subsequent chapters focus upon the development,production and analysis of these substances. Finally the book moveson to explore the science, biotechnology and medical applicationsof specific biotech products categories. These include not onlyprotein-based substances but also nucleic acid and cell-basedproducts. introduces essential principles underlining modernbiotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimedspecifically at pharmacy and medical students includes specific ‘product category chapters’focusing on the pharmaceutical, medical and therapeutic propertiesof numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineeringand how these drugs are developed. includes numerous relevant case studies to enhance studentunderstanding no prior knowledge of protein structure is assumed

Pharmaceutical Biotechnology

Author : Daan J. A. Crommelin
ISBN : 9781461464860
Genre : Medical
File Size : 33. 8 MB
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This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech.

Pharmaceutical Biotechnology

Author : Carlos A. Guzmán
ISBN : 1441911324
Genre : Medical
File Size : 36. 4 MB
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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.

Vaccine Development And Manufacturing

Author : Emily P. Wen
ISBN : 9781118870907
Genre : Technology & Engineering
File Size : 20. 1 MB
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Vaccine Manufacturing and Production is an invaluablereference on how to produce a vaccine - from beginning to end -addressing all classes of vaccines from aprocessing, production, and regulatory viewpoint. It willprovide comprehensive information on the various fields involved inthe production of vaccines, from fermentation, purification,formulation, to regulatory filing and facility designs. In recentyears, there have been tremendous advances in all aspects ofvaccine manufacturing. Improved technology and growth media havebeen developed for the production of cell culture with high celldensity or fermentation. Vaccine Manufacturing andProduction will serve as a reference on all aspects of vaccineproduction by providing an in-depth description of the availabletechnologies for making different types of vaccines and the currentthinking in facility designs and supply issues. This book willprovide insight to the issues scientists face when producing avaccine, the steps that are involved, and will serve asa reference tool regarding state-of-the-art vaccinemanufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a processpoint of view- fermentation to purification to formulationdevelopments; from a production point of view - from facilitydesign to manufacturing; and from a regulatory point of view -requirements from government agencies Authors from different major pharmaceutical and biotechnologycompanies Describes the challenges and issues involved in vaccineproduction and manufacturing of the different classes of vaccines,an area not covered by other books currently on the market

Molecular Farming

Author : Rainer Fischer
ISBN : 9783527605811
Genre : Science
File Size : 80. 21 MB
Format : PDF, Kindle
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Here, authors from academia and industry provide an exciting overview of current production technologies and the fascinating possibilities for future applications. Topics include chloroplast-derived antibodies, biopharmaceuticals and edible vaccines, production of antibodies in plants and plant cell suspension cultures, production of spider silk proteins in plants, and glycosylation of plant produced proteins. The whole is rounded off by chapters on the demands and expectations made on molecular farming by pharmaceutical corporations and the choice of crop species in improving recombinant protein levels. Of interest to biotechnologists, gene technologists, molecular biologists and protein biochemists in university as well as the biotechnological and pharmaceutical industries.

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