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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 | ||
| ||
Development of vaccines [[electronic resource] ] : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava
| Development of vaccines [[electronic resource] ] : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina | 615/.372 |
| Altri autori (Persone) |
Manmohan Singh <1964 November 8->
SrivastaIndresh K |
| Soggetto topico |
Vaccines
Drug development Drug stability |
| ISBN |
1-283-17565-7
9786613175656 1-118-02363-3 1-118-02364-1 1-118-02362-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Microbial vaccines design : the reverse vaccinology approach / Roberto Rosini, Michele A. Barocchi, Rino Rappuoli -- Design and development of recombinant vaccines with viral properties / Gerd Lipowsky, Martin F. Bachmann -- Tools for vaccine design : prediction and validation of highly immunogenic and conserved class II epitopes, and development of epitope-driven vaccines / Anne S. De Groot ... [et al.] -- Virus like-particle vaccines advantages and challenges / Ted M. Ross ... [et al.] -- Design platforms of nanocapsules for human therapeutics or vaccines / Masaaki Kawano ... [et al.] -- Designing immunogens for vaccine development in reference to HIV / Aemro Kassa ... [et al.] --
Expression and purification of recombinant proteins for vaccine applications / Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava -- DNA vaccines for infectious diesase / Samuel Stepenson, Manmohan Singh, Indresh K. Srivastava -- Developing stable cell lines for the production of vaccine antigens / Xiaotian Zhong ... [et al.] -- Spectroscopy of vaccines / C. Russell Middaugh, Sangeeta B. Joshi -- Biophysical characterization of protein antigens within vaccine formulations / Padima Malyala, Derek O'Hagan, Manmohan Singh -- Structural characteristics predict the stability of HIV / Zohar Biron ... [et al.] -- Selection of optimal adjuvants and product factors that affect vaccine immunogenicity / Wei Wang, Manmohan Singh -- Lyophilization and stabilization of vaccines / James Chesko ... [et al.] -- Effect of buffers and stabilizers on vaccine stability and efficacy / Shireesh P. Apte, Sydney Ugwu -- Selection of final product containers / Luis Baez, Adrian Distler -- From the lab to the clinic : filing a phase I IND for an investigational vaccine / Kenneth G. Surowitz. |
| Record Nr. | UNINA-9910139627903321 |
| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of vaccines : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava
| Development of vaccines : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina | 615/.372 |
| Altri autori (Persone) |
Manmohan Singh <1964 November 8->
SrivastaIndresh K |
| Soggetto topico |
Vaccines
Drug development Drug stability |
| ISBN |
9786613175656
9781283175654 1283175657 9781118023631 1118023633 9781118023648 1118023641 9781118023624 1118023625 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Microbial vaccines design : the reverse vaccinology approach / Roberto Rosini, Michele A. Barocchi, Rino Rappuoli -- Design and development of recombinant vaccines with viral properties / Gerd Lipowsky, Martin F. Bachmann -- Tools for vaccine design : prediction and validation of highly immunogenic and conserved class II epitopes, and development of epitope-driven vaccines / Anne S. De Groot ... [et al.] -- Virus like-particle vaccines advantages and challenges / Ted M. Ross ... [et al.] -- Design platforms of nanocapsules for human therapeutics or vaccines / Masaaki Kawano ... [et al.] -- Designing immunogens for vaccine development in reference to HIV / Aemro Kassa ... [et al.] --
Expression and purification of recombinant proteins for vaccine applications / Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava -- DNA vaccines for infectious diesase / Samuel Stepenson, Manmohan Singh, Indresh K. Srivastava -- Developing stable cell lines for the production of vaccine antigens / Xiaotian Zhong ... [et al.] -- Spectroscopy of vaccines / C. Russell Middaugh, Sangeeta B. Joshi -- Biophysical characterization of protein antigens within vaccine formulations / Padima Malyala, Derek O'Hagan, Manmohan Singh -- Structural characteristics predict the stability of HIV / Zohar Biron ... [et al.] -- Selection of optimal adjuvants and product factors that affect vaccine immunogenicity / Wei Wang, Manmohan Singh -- Lyophilization and stabilization of vaccines / James Chesko ... [et al.] -- Effect of buffers and stabilizers on vaccine stability and efficacy / Shireesh P. Apte, Sydney Ugwu -- Selection of final product containers / Luis Baez, Adrian Distler -- From the lab to the clinic : filing a phase I IND for an investigational vaccine / Kenneth G. Surowitz. |
| Record Nr. | UNINA-9910813272203321 |
| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Novel immune potentiators and delivery technologies for next generation vaccines / / Manmohan Singh, editor
| Novel immune potentiators and delivery technologies for next generation vaccines / / Manmohan Singh, editor |
| Edizione | [1st ed. 2013.] |
| Pubbl/distr/stampa | New York, : Springer, c2013 |
| Descrizione fisica | 1 online resource (367 p.) |
| Disciplina | 615.6 |
| Altri autori (Persone) | Manmohan Singh <1964 November 8-> |
| Soggetto topico |
Immunology
Vaccines - Biotechnology Vaccines |
| ISBN | 1-4614-5380-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Critical parameters that govern the optimization of vaccine formulations -- Development of Biophysical assays to better understand vaccine formulation stability -- Rational design of vaccine formulations -- Monitoring stability and efficacy of multi-valent vaccine formulations.- Overcoming challenges of multi component alum formulations.- Delivery of various TLR adjuvants using alum platform -- History of use of emulsions for vaccine delivery -- MF59 o/w emulsion : History and safety over the last 2 decades -- Optimizing novel nanoemulsions for delivery of next generation antigens and adjuvants -- Modulating vaccine responses with innate immunity : Use of PLGA nanoparticles for delivering multiple TLR agonists -- Shape matters : Role of nanoparticle shape in induction of immune responses to a vaccine. . |
| Record Nr. | UNINA-9910437605403321 |
| New York, : Springer, c2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Vaccine adjuvants and delivery systems / / edited by Manmohan Singh
| Vaccine adjuvants and delivery systems / / edited by Manmohan Singh |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2007 |
| Descrizione fisica | 1 online resource (470 p.) |
| Disciplina | 615/.372 |
| Altri autori (Persone) | Manmohan Singh <1964 November 8-> |
| Soggetto topico |
Vaccines
Immunological adjuvants |
| ISBN |
9786610900268
9781280900266 1280900261 9780470134924 0470134925 9780470134931 0470134933 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Development of vaccine adjuvants : a historical perspective / Gary Ott and Gary Van Nest -- Antigen processing and presentation / Subash Sad -- Mechanisms of adjuvant action / Nils Lycke -- Aluminum-containing adjuvants : properties, formulation, and use / Stanley L. Hem and Harm HogenEsch -- MF59 : a safe and potent oil-in-water emulsion adjuvant / Derek T. O'Hagan and Manmohan Singh -- TLR4 agonists as vaccine adjuvants / David A. Johnson and Jory R. Baldridge -- Immunostimulatory CpG oligodeoxynucleotides as vaccine adjuvants / Dennis M. Klinman, Debbie Currie, and Hidekazu Shirota -- Small molecule immunopotentiators as vaccine adjuvants / Fengfeng Xu, Nicholas M. Valiante, and Jeffrey B. Ulmer -- New ISCOMs meet unsettled vaccine demands / Bror Morein ... [et al.] -- Surface-charged poly(lactide-co-glycolide) microparticles as novel antigen delivery systems / Manmohan Singh ... [et al.] -- Liposomal cytokines and liposomes targeted to co-stimulatory molecules as adjuvants for HIV subunit vaccines / Bulent Ozpolat and Lawrence B. Lachman -- Archaeosome vaccine adjuvants for cross-priming CD8+ T-cell immunity / Lakshmi Krishnan and G. Dennis Sprott -- Mucosal adjuvants and delivery systems / Michael Vajdy -- Cytokines as vaccine adjuvants / Nejat K. Egilmez -- Polyphosphazenes as vaccine adjuvants / Alexander K. Andrianov -- Vaccine delivery by transdermal electroporation / Amit Misra -- Nonclinical safety assessment of vaccines and the evaluation of novel adjuvants and delivery systems / Jose A. Lebron ... [et al.] -- Safety evaluation of vaccine adjuvants / Erik B. Lindblad. |
| Record Nr. | UNINA-9911018974303321 |
| Hoboken, N.J., : Wiley-Interscience, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||