Produktbild: Biological Drug Products

Biological Drug Products Development and Strategies

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

07.10.2013

Herausgeber

Wei Wang + weitere

Verlag

John Wiley & Sons

Seitenzahl

744

Maße (L/B/H)

24/16,1/4,4 cm

Gewicht

1273 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-1-118-14889-1

Beschreibung

Rezension

"Thus, it will be a valuable resource for both novice and expert alike." (ChemMedChem, 1 October 2014)

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

07.10.2013

Herausgeber

Verlag

John Wiley & Sons

Seitenzahl

744

Maße (L/B/H)

24/16,1/4,4 cm

Gewicht

1273 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-1-118-14889-1

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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Die Leseprobe wird geladen.
  • Produktbild: Biological Drug Products
  • Dedication
     
    Preface
     
    Part 1. General Aspects 1
     
    Chapter 1. An Overview of Discovery and Development Process For Biologics 3
    Heather H. Shih, Paula Miller and Douglas C. Harnish
     
    Chapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31
    Liangbiao George Hu, David W. Clarke
     
    Chapter 3 Clinical Assessment of Biologics Agents 57
    Lesley Ann Saketkoo, Shikha Mittoo and Luis R. Espinoza
     
    Chapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75
    Richard Kingham, Gabriela Klasa and Krista Hessler Carver
     
    Chapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111
    Srikumaran Melethil
     
    Chapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133
    James E. Akers and James P. Agalloco
     
    Part 2. Proteins/Peptides 163
     
    Chapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165
    Feng Li, Amy (Yijuan) Shen and Ashraf Amanullah
     
    Chapter 8. Protein/Peptide Purification and Virus Reduction 203
    Beckley K. Nfor, Esteban Freydell and Marcel Ottens
     
    Chapter 9. Chemical and Genetic Modification 233
    M Farys, C Ginn, G Badescu, K Peciak, E Pawlisz, H Khalili and S Brocchini
     
    Chapter 10. Analytical Characterization of Proteins/Peptides 285
    Yajun Jennifer Wang and Brian Hosken
     
    Chapter 11. Protein/Peptide Formulation Development 323
    Satoshi Ohtake and Wei Wang
     
    Chapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367
    Umang S. Shah
     
    Part 3. Vaccines 409
     
    Chapter 13. Vaccine Development - History, Current Status and Future Trends 411
    Leo Van Der Pol and Jean-Pierre Amorij
     
    Chapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437
    Rajesh K. Gupta
     
    Chapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469
    Martinus A.H. Capelle, Emilie Poirier and Tudor Arvinte
     
    Part 4. Novel Biologics 487
     
    Chapter 16. The State Of The Art and Future of Gene Medicines 489
    Frank Jacobs, Stephanie C. Gordts and Bart De Geest
     
    Chapter 17. Nucleic Acid Vaccines 531
    Rachel Buglione-Corbett, John Suschak, Shixia Wang and Shan Lu
     
    Chapter 18. Multifunctional Polymeric Nano-Systems for Rna Interference Therapy 569
    Arun Iyer, Shanthi Ganesh, Qiong L. Zhou and Mansoor Amiji
     
    Chapter 19. Advent and Maturation of Regenerative Medicine 601
    Abner M. Mhashilkar and Anthony Atala
     
    Part 5. Product Administration/Delivery 629
     
    Chapter 20. Conventional and Novel Container Closure/Delivery Systems 631
    Joseph Wong and Mahesh V. Chaubal
     
    Chapter 21. Controlled-Release Systems for Biologics 655
    Mayura Oak, Rhishikesh Mandke, Buddhadev Layek, Gitanjali Sharma and Jagdish Singh
     
    Chapter 22. Routes of Delivery for Biological Drug Products 677
    Darrell J. Irvine, Xingfang Su and Brandon Kwong
     

    INDEX 725