LEADER 05404nam 2200661 450 001 9910140481503321 005 20210604085713.0 010 $a3-527-67370-9 010 $a3-527-67368-7 010 $a3-527-67371-7 035 $a(CKB)2670000000585610 035 $a(EBL)1889228 035 $a(SSID)ssj0001432909 035 $a(PQKBManifestationID)11810498 035 $a(PQKBTitleCode)TC0001432909 035 $a(PQKBWorkID)11413160 035 $a(PQKB)10186743 035 $a(MiAaPQ)EBC1889228 035 $a(Au-PeEL)EBL1889228 035 $a(CaPaEBR)ebr10996822 035 $a(CaONFJC)MIL678778 035 $a(OCoLC)898422725 035 $a(PPN)189546603 035 $a(EXLCZ)992670000000585610 100 $a20150107h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aContinuous processing in pharmaceutical manufacturing /$fedited by Ganapathy Subramanian 210 1$aWeinheim, Germany :$cWiley-VCH Verlag GmbH & Co. KGaA,$d2015. 210 4$dİ2015 215 $a1 online resource (531 p.) 300 $aDescription based upon print version of record. 311 $a1-322-47496-6 311 $a3-527-33595-1 320 $aIncludes bibliographical references and index. 327 $aContinuous 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 327 $a1.3.2 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 327 $a3. 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 327 $a3.3.2 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 327 $a3.4.5 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 327 $a4.2.1.3 Impurity Precipitation 330 $aWith 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 606 $aPharmaceutical industry$xQuality control 606 $aPharmaceutical industry$xResearch 615 0$aPharmaceutical industry$xQuality control. 615 0$aPharmaceutical industry$xResearch. 676 $a338.4561615 702 $aSubramanian$b Ganapathy 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910140481503321 996 $aContinuous processing in pharmaceutical manufacturing$92190386 997 $aUNINA