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010 a| 2013016910;

020 a| 9781118695227 (epub);

020 a| 9781118695036 (pdf);

020 a| 9781118695081 ( mobi);

020 z| 9781118148891 (cloth);

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245 00 a| Biological drug productsh| [electronic resource] :b| development and strategies /c| edited by Wei Wang, Manmohan Singh.;

260 a| Hoboken, N.J. :b| Wiley,;

300 a| 1 online resource.;

504 a| Includes bibliographical references and index.;

505 0 a| An overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish -- Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke -- Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza -- Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver -- Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil -- Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco -- Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah -- Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens -- Chemical and genetic modification / M Farys ... [et al.] -- Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken -- Protein/peptide formulation development / Satoshi Ohtake and Wei Wang -- Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah -- Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij -- Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta -- Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte -- The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest -- Nucleic acid vaccines / Rachel Buglione-Corbett ... [et al.] -- Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.] -- Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala -- Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal -- Controlled-release systems for biologics / Mayura Oak ... [et al.] -- Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.;

506 a| Available only to authorized users.;

538 a| Mode of access: World Wide Web;

588 a| Description based on print version record and CIP data provided by publisher.;

650 12 a| Biological Agentsx| pharmacology.?| UNAUTHORIZED;

650 12 a| Biological Agentsx| therapeutic use.?| UNAUTHORIZED;

650 22 a| Drug Delivery Systems.=| ^A927384;

650 22 a| Drug Discovery.=| ^A1013013;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Wang, Wei,d| 1957 March 10-?| UNAUTHORIZED;

700 1 a| Manmohan Singh,d| 1964 November 8-=| ^A1207609;

776 08 i| Print version:t| Biological drug productsd| Hoboken, N.J. : John Wiley & Sons, c2014z| 9781118148891w| (DLC) 2013016301;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=1368915;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER188;

949 a| CLICK ON WEB ADDRESSw| ASISh| HSL77;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 3991369-2001l| HSLELECm| HSLr| Ys| Yt| HEBKu| 1/1/2016x| EBOOKz| HERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 3991369-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 1/1/2016x| EBOOKz| JERESOURCE;

Biological drug products development and strategies / edited by Wei Wang, Manmohan Singh.

Other author	Wang, Wei, 1957 March 10-
Other author	Manmohan Singh, 1964 November 8-
Format	Electronic
Publication Info	Hoboken, N.J. : Wiley,
Description	1 online resource.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	Biological Agents--pharmacology. Biological Agents--therapeutic use. Drug Delivery Systems. Drug Discovery.

Contents	An overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish -- Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke -- Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza -- Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver -- Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil -- Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco -- Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah -- Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens -- Chemical and genetic modification / M Farys ... [et al.] -- Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken -- Protein/peptide formulation development / Satoshi Ohtake and Wei Wang -- Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah -- Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij -- Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta -- Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte -- The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest -- Nucleic acid vaccines / Rachel Buglione-Corbett ... [et al.] -- Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.] -- Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala -- Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal -- Controlled-release systems for biologics / Mayura Oak ... [et al.] -- Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Source of description	Description based on print version record and CIP data provided by publisher.
Issued in other form	Print version: Biological drug products Hoboken, N.J. : John Wiley & Sons, c2014 9781118148891
Genre/form	Electronic books.
LCCN	2013016910
ISBN	9781118695227 (epub)
ISBN	9781118695036 (pdf)
ISBN	9781118695081 ( mobi)

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Biological drug products development and strategies / edited by Wei Wang, Manmohan Singh.

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