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 biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different p.

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 …