WHO Expert Committee on Biological Standardization

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241209939
Release Date: 2015-06-30
Genre: Business & Economics

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendations Guidelines and guidance documents. Following these discussions a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above three WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–4). Finally all additions and discontinuations made during the 2014 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.

WHO Expert Committee on Biological Standardization

Author: WHO Expert Committee on Biological Standardization. Meeting
Publisher: World Health Organization
ISBN: 9789241209410
Release Date: 2007-12-15
Genre: Business & Economics

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality safety and efficacy of vaccines blood products and other biological medicines and the establishment of international biological reference standards for these products and related diagnostic devices. The report of particular relevance to manufacturers and national regulatory authorities starts with a discussion of general issues brought to the Committee's attention. The second part of the report contains written specifications that establish international regulatory expectations for the following products; DNA vaccines pertussis (whole cell) vaccine plasma (human) for fractionation rabies vaccine and rotavirus vaccine. The report also provides a risk assessment and defines conditions for the safe production of pandemic strain influenza vaccines. The third part of the report provides information on the status and development of international reference materials for various antibodies antigens blood products and related substances and in vitro diagnostic devices.

Environmental Biology for Engineers and Scientists

Author: David A. Vaccari
Publisher: John Wiley & Sons
ISBN: 9780471741787
Release Date: 2005-10-27
Genre: Science

The growth of the environmental sciences has greatly expanded thescope of biological disciplines today's engineers have to dealwith. Yet, despite its fundamental importance, the full breadth ofbiology has been given short shrift in most environmentalengineering and science courses. Filling this gap in the professional literature, EnvironmentalBiology for Engineers and Scientists introduces students ofchemistry, physics, geology, and environmental engineering to abroad range of biological concepts they may not otherwise beexposed to in their training. Based on a graduate-level coursedesigned to teach engineers to be literate in biological conceptsand terminology, the text covers a wide range of biology withoutmaking it tedious for non-biology majors. Teaching aids include: * Notes, problems, and solutions * Problem sets at the end of each chapter * PowerPoints(r) of many figures A valuable addition to any civil engineering and environmentalstudies curriculum, this book also serves as an importantprofessional reference for practicing environmental professionalswho need to understand the biological impacts of pollution.

6th World Congress of Biomechanics WCB 2010 1 6 August 2010 Singapore

Author: Chwee Teck Lim
Publisher: Springer Science & Business Media
ISBN: 3642145159
Release Date: 2010-08-09
Genre: Technology & Engineering

Biomechanics covers a wide field such as organ mechanics, tissue mechanics, cell mechanics to molecular mechanics. At the 6th World Congress of Biomechanics WCB 2010 in Singapore, authors presented the largest experimental studies, technologies and equipment. Special emphasis was placed on state-of-the-art technology and medical applications. This volume presents the Proceedings of the 6th WCB 2010 which was hold in conjunction with 14th International Conference on Biomedical Engineering (ICBME) & 5th Asia Pacific Conference on Biomechanics (APBiomech). The peer reviewed scientific papers are arranged in the six themes Organ Mechanics, Tissue Mechanics, Cell Mechanics, Molecular Mechanics, Materials, Tools, Devices & Techniques, Special Topics.

Fundamentals of Modern Bioprocessing

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9781466585744
Release Date: 2015-10-28
Genre: Medical

Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.

Anatomie und menschliche Bewegung

Author: Nigel Palastanga
Publisher: "Elsevier,Urban&FischerVerlag"
ISBN: 9783437293016
Release Date: 2014-09-26
Genre: Medical

Strukturen und Funktionen des muskuloskelettalen Systems Anatomie und menschliche Bewegung nimmt Sie mit auf eine systematische und detaillierte Reise durch die Anatomie und erklärt Ihnen u.a. wie und warum Bewegung überhaupt möglich ist. Eindrucksvoll in Wort und Bild lernen Sie z.B. die Bewegungsmuster beim Boxen, Ballwurf, Liegestütz, Treppensteigen u.v.m. kennen. Sie erfahren das Wichtigste über Biomechanik, Faszien, Bewegungsmuster und erhalten Palpationshinweise. Mehr als 450 hochwertige farbige Abbildungen unterstützen das Verständnis. Anatomie und menschliche Bewegung ist die optimale Ergänzung zu Ihren Anatomie-Atlanten und Lehrbüchern, denn stärker als in anderen Werken steht die Bewegung mit all ihren Facetten im Vordergrund: Hier werden die funktionellen Zusammenhänge praxisbezogen erklärt und alltägliche Bewegungsmuster anschaulich beschrieben. Das macht es Ihnen leicht anatomische Zusammenhänge nachzuvollziehen und sich dauerhaft zu merken. Dies unterstützt Sie bei der Vorbereitung für den Unterricht, z.B. in den Fächern Funktionelle Anatomie oder Biomechanik sowie bei Prüfungen und im Berufsalltag Das Buch behandelt obere Extremität, untere Extremität, Rumpf (inkl. inneren Organen), Hals und Kopf. Systematisch werden Knochen, Muskeln, Gelenke, Nervensystem, Blutversorgung und Lymphsystem der jeweiligen Region beschrieben. Die Inhalte richten sich an angehende und praktizierende Physiotherapeuten, Ergotherapeuten, Sportwissenschaftler.

Chemie f r Dummies

Author: John T. Moore
Publisher: John Wiley & Sons
ISBN: 9783527816934
Release Date: 2018-04-27
Genre: Science

Wenn es knallt und stinkt, dann ist Chemie im Spiel! "Chemie für Dummies" macht deutlich, dass Chemie nicht nur aus Formeln, sondern vor allem aus unzähligen interessanten Stoffen, Versuchen und Reaktionen besteht. In diesem etwas anderen Chemie-Buch lernen Sie die Grundlagen der Chemie kennen und erfahren, wo sich chemische Phänomene im Alltag bemerkbar machen. John T. Moore macht für Sie so schwer vorstellbare Begriffe wie Atom, Base oder Molekül begreiflich und zeigt, wie man mit dem Periodensystem umgeht. Mit Übungsaufgaben am Ende eines jeden Kapitels können Sie dann noch Ihr Wissen überprüfen.

Vaccinology

Author: Gregg N. Milligan
Publisher: John Wiley & Sons
ISBN: 9781118636527
Release Date: 2014-12-04
Genre: Medical

Vaccinology: An Essential Guide outlines in a clear,practical format the entire vaccine development process, fromconceptualization and basic immunological principles through toclinical testing and licensing of vaccines. With anoutstanding introduction to the history and practice ofvaccinology, it also guides the reader through the basic sciencerelating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economicand geographical issues that drive vaccine development and trials,it also presents vaccine delivery strategies, novel vaccineplatforms (including experimental vaccines and pathogens), antigendevelopment and selection, vaccine modelling, and the developmentof vaccines against emerging pathogens and agents of bioterror.There are also sections devoted to veterinary vaccines andassociated regulatory processes. Vaccinology: An Essential Guide is a perfect tool fordesigned for undergraduate and graduate microbiologists andimmunologists, as well as residents, fellows and trainees ofinfectious disease and vaccinology. It is also suitable for allthose involved in designing and conducting clinical vaccine trials,and is the ideal companion to the larger reference bookVaccinology: Principles and Practice.