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Biological drug products : development and strategies / / edited by Wei Wang, Manmohan Singh
| Biological drug products : development and strategies / / edited by Wei Wang, Manmohan Singh |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2013 |
| Descrizione fisica | 1 online resource (746 p.) |
| Disciplina | 615.1/9 |
| Altri autori (Persone) |
WangWei <1957 March 10->
Manmohan Singh <1964 November 8-> |
| Soggetto topico |
Drug development
Drugs - Research |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-118-69503-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910452528403321 |
| Hoboken, New Jersey : , : Wiley, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biological drug products : development and strategies / / edited by Wei Wang, Manmohan Singh
| Biological drug products : development and strategies / / edited by Wei Wang, Manmohan Singh |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2013 |
| Descrizione fisica | 1 online resource (746 p.) |
| Disciplina | 615.1/9 |
| Altri autori (Persone) |
WangWei <1957 March 10->
Manmohan Singh <1964 November 8-> |
| Soggetto topico |
Drug development
Drugs - Research |
| ISBN |
1-118-69522-4
1-118-69503-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910790546703321 |
| Hoboken, New Jersey : , : Wiley, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biological drug products : development and strategies / / edited by Wei Wang, Manmohan Singh
| Biological drug products : development and strategies / / edited by Wei Wang, Manmohan Singh |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2013 |
| Descrizione fisica | 1 online resource (746 p.) |
| Disciplina | 615.1/9 |
| Altri autori (Persone) |
WangWei <1957 March 10->
Manmohan Singh <1964 November 8-> |
| Soggetto topico |
Drug development
Drugs - Research |
| ISBN |
1-118-69522-4
1-118-69503-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910807967603321 |
| Hoboken, New Jersey : , : Wiley, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||