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Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product - Tapa dura
Sinopsis
Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies.
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Acerca del autor
Steven J. Shire is currently consulting and serving as an adjunct faculty member of the USC School of Pharmacy and University of Connecticut School of Pharmaceutical Sciences. He was at Genentech for 32 years where the majority of his career was in the pharmaceutical development department. He retired in June 2013 as Staff Scientist in the Late Stage Pharmaceutical Development Department. He has been responsible for directing research and development of formulations for a variety of recombinant human proteins including Pulmozyme® and Xolair®. Dr. Shire has served as the chair of the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Section, and was elected as a Fellow of AAPS in 1998 and member at large to the AAPS Executive Council in 2001. He has published over 80 reviews and papers dealing with various aspects of formulation and pharmaceutical development of therapeutic proteins.
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- EditorialWoodhead Publishing Ltd
- Año de publicación2015
- ISBN 10 0081002963
- ISBN 13 9780081002964
- EncuadernaciónTapa dura
- IdiomaInglés
- Número de páginas224
- Contacto del fabricanteno disponible
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Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product
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Woodhead Publishing 2015-04-30, 2015
ISBN 10: 0081002963
ISBN 13: 9780081002964
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Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product
Impresión bajo demandaLibrería: Brook Bookstore On Demand, Napoli, NA, Italia
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Condición: new. Questo è un articolo print on demand. Nº de ref. del artículo: 7eefd5bd070d21c4215c00b2769e0026
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Monoclonal Antibodies
Librería: Majestic Books, Hounslow, Reino Unido
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Condición: New. pp. 208. Nº de ref. del artículo: 322556449
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Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product
Librería: Revaluation Books, Exeter, Reino Unido
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Hardcover. Condición: Brand New. 224 pages. 9.25x6.25x0.75 inches. In Stock. Nº de ref. del artículo: __0081002963
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Monoclonal Antibodies
Librería: Books Puddle, New York, NY, Estados Unidos de America
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Condición: New. pp. 208. Nº de ref. del artículo: 26323907070
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Monoclonal Antibodies
Publicado por
Elsevier Science Apr 2015, 2015
ISBN 10: 0081002963
ISBN 13: 9780081002964
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Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Alemania
Calificación del vendedor: 5 de 5 estrellas
Buch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. 224 pp. Englisch. Nº de ref. del artículo: 9780081002964
Cantidad disponible: 2 disponibles
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Monoclonal Antibodies
Librería: Biblios, Frankfurt am main, HESSE, Alemania
Calificación del vendedor: 5 de 5 estrellas
Condición: New. pp. 208. Nº de ref. del artículo: 18323907060
Cantidad disponible: 3 disponibles
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Monoclonal Antibodies : Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product
Impresión bajo demandaLibrería: AHA-BUCH GmbH, Einbeck, Alemania
Calificación del vendedor: 5 de 5 estrellas
Buch. Condición: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. Nº de ref. del artículo: 9780081002964
Cantidad disponible: 2 disponibles
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Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product
Librería: dsmbooks, Liverpool, Reino Unido
Calificación del vendedor: 4 de 5 estrellas
Hardcover. Condición: New. New. book. Nº de ref. del artículo: D8S0-3-M-0081002963-6
Cantidad disponible: 1 disponibles