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Continuous processing in pharmaceutical manufacturing / / edited by Ganapathy Subramanian
| Continuous processing in pharmaceutical manufacturing / / edited by Ganapathy Subramanian |
| Pubbl/distr/stampa | Weinheim, Germany : , : Wiley-VCH Verlag GmbH & Co. KGaA, , 2015 |
| Descrizione fisica | 1 online resource (531 p.) |
| Disciplina | 338.4561615 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Pharmaceutical industry - Research |
| ISBN |
3-527-67370-9
3-527-67368-7 3-527-67371-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Continuous Processing in Pharmaceutical Manufacturing; Contents; List of Contributors; Preface; 1. Proteins Separation and Purification by Expanded Bed Adsorption and Simulated Moving Bed Technology; 1.1 Introduction; 1.2 Protein Capture by Expanded Bed Technology; 1.2.1 Adsorbent Materials; 1.2.2 Expanded Bed Adsorption/Desorption of Protein; 1.2.3 Modeling of the Expanded Bed; 1.3 Proteins Separation and Purification by Salt Gradient Ion Exchange SMB; 1.3.1 Adsorption Isotherms and Kinetics of BSA and Myoglobin on Ion Exchange Resins
1.3.2 Salt Gradient Formation and Process Design for IE-SMB Chromatography1.3.3 Separation Region of Salt Gradient IE-SMB Chromatography; 1.3.4 Proteins Separation and Purification in Salt Gradient IE-SMB with Open Loop Configuration; 1.4 Conclusion; References; 2. BioSMB Technology as an Enabler for a Fully Continuous Disposable Biomanufacturing Platform; 2.1 Introduction; 2.2 Integrated Continuous Bioprocessing; 2.3 Multicolumn Chromatography; 2.4 BioSMB Technology; 2.5 Fully Disposable Continuous Processing; 2.6 Case Studies; 2.7 Regulatory Aspects; 2.8 Conclusions; References 3. Impact of Continuous Processing Techniques on Biologics Supply Chains3.1 Introduction; 3.1.1 The Biologics Industry; 3.1.2 The Biologics Value Chain; 3.1.3 Downstream Purification Costs; 3.2 Chromatography Techniques Used in Downstream Purification of Biomolecules; 3.2.1 Need for Continuous Manufacturing in Downstream Purification; 3.2.2 The Multicolumn Countercurrent Solvent Gradient Purification Chromatography System; 3.3 Next-Generation Biologic Products - Bispecific Monoclonal Antibodies; 3.3.1 Major Biopharma Companies and Their Interest in Bispecific Mabs 3.3.2 Challenges in Purification of Bispecific Monoclonal Antibodies3.4 Improving the Downstream Processing of Bispecific Mabs by Introduction of MCSGP in the Value Chain; 3.4.1 Advantages of Utilizing MCSGP Process in Bispecific Mabs Purification as Compared to Batch Chromatography; 3.4.2 Impact of MCSGP System on Biologic Supply Chains; 3.4.3 Impact on Patent Approval Structure of Biologic Drugs; 3.4.3.1 For a Manufacturer Who Already has a Biologic Drug in the Market; 3.4.3.2 For a Manufacturer Who is Developing a Biologic Drug; 3.4.4 Impact on Big Biopharma Companies 3.4.5 Impact on the Chromatography Market3.4.6 Limitations of the MCSGP System; 3.5 Conclusion; 3.6 Further Research; Acknowledgments; 3.A Appendix/Additional Information; 3.A.1 Regulatory Structure for Bispecific Monoclonal Antibodies; 3.A.1.1 Regulatory Compliance Comparison between US, EU, and Emerging Economies; References; 4. Integrating Continuous and Single-Use Methods to Establish a New Downstream Processing Platform for Monoclonal Antibodies; 4.1 Introduction; 4.2 Harvest and Clarification; 4.2.1 The Challenge and Technology Selection; 4.2.1.1 Centrifugation; 4.2.1.2 Filtration 4.2.1.3 Impurity Precipitation |
| Record Nr. | UNINA-9910140481503321 |
| Weinheim, Germany : , : Wiley-VCH Verlag GmbH & Co. KGaA, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Iranian journal of pharmaceutical research : IJPR
| Iranian journal of pharmaceutical research : IJPR |
| Pubbl/distr/stampa | Tehran, : School of Pharmacy, Shaheed Behesti University of Medical Sciences and Health Services |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Pharmaceutical industry
Pharmaceutical industry - Research Technology, Pharmaceutical Drug Industry |
| Soggetto genere / forma | Periodical |
| ISSN | 1726-6890 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910143979503321 |
| Tehran, : School of Pharmacy, Shaheed Behesti University of Medical Sciences and Health Services | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Journal of pharmaceutical health services research
| Journal of pharmaceutical health services research |
| Pubbl/distr/stampa | [Chichester, Sussex] : , : Wiley-Blackwell : , : Royal Pharmaceutical Society of Great Britain, , 2010- |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Pharmacy - Research
Pharmaceutical industry - Research Drugs - Research Medical care - Research Public health - Research Epidemiology - Research Health Services Research Economics, Pharmaceutical |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 1759-8893 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
J. pharm. health serv. res
JPHSR |
| Record Nr. | UNISA-996213000403316 |
| [Chichester, Sussex] : , : Wiley-Blackwell : , : Royal Pharmaceutical Society of Great Britain, , 2010- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Journal of pharmaceutical health services research
| Journal of pharmaceutical health services research |
| Pubbl/distr/stampa | [Chichester, Sussex] : , : Wiley-Blackwell : , : Royal Pharmaceutical Society of Great Britain, , 2010- |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Pharmacy - Research
Pharmaceutical industry - Research Drugs - Research Medical care - Research Public health - Research Epidemiology - Research Health Services Research Economics, Pharmaceutical |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 1759-8893 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
J. pharm. health serv. res
JPHSR |
| Record Nr. | UNINA-9910143077003321 |
| [Chichester, Sussex] : , : Wiley-Blackwell : , : Royal Pharmaceutical Society of Great Britain, , 2010- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
