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Continuous Processing in Pharmaceutical Manufacturing.
With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharm...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
Wiley,
2014.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.