LEADER 05701nam 22007215 450 001 9910800113003321 005 20240110103337.0 010 $a3-031-45669-6 024 7 $a10.1007/978-3-031-45669-5 035 $a(MiAaPQ)EBC31065856 035 $a(Au-PeEL)EBL31065856 035 $a(DE-He213)978-3-031-45669-5 035 $a(EXLCZ)9929575817800041 100 $a20240110d2023 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aBiopharmaceutical Manufacturing$b[electronic resource] $eProgress, Trends and Challenges /$fedited by Ralf Pörtner 205 $a1st ed. 2023. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2023. 215 $a1 online resource (497 pages) 225 1 $aCell Engineering,$x2542-9515 ;$v11 311 08$aPrint version: Pörtner, Ralf Biopharmaceutical Manufacturing Cham : Springer International Publishing AG,c2024 9783031456688 327 $aPart I: Manufacturing of Recombinant Therapeutic Proteins -- Chapter 1. Single-Use Systems in Biopharmaceutical Manufacture: State of the Art and Recent Trends (Jossen et al.) -- Chapter 2. Recent Developments in Bioprocess Monitoring Systems (Rahmatnejad et al.) -- Chapter 3. Advances in Characterization of Industrial Bioreactors for Cell Culture Process (Fitschen et al.) -- Chapter 4. Continuous Bioprocessing for Upstream Process - Perfusion Process (Chotteau et al.) -- Chapter 5. Continuous Bioprocessing for Downstream (Gerstweiler) -- Chapter 6. Towards Digital Twin for Biopharmaceutical Processes: Concept and Progress (Ding et al.) -- Chapter 7. Integrated Process and Supply Chain Design and Optimization (Triantafyllou et al.) -- Chapter 8. Production of Complex Proteins in Plants ? From Farming to Manufacturing (Nausch et al.) -- Chapter 9. Manufacturing of Recombinant Proteins Using Quality by Design (QbD) Methodology: Current Trend and Challenges (Shin and Landauer) -- Chapter 10. Biopharma 4.0 for Biologics Manufacturing Under Pandemic Constraints (Schmidt et al.) -- Chapter 11. Biopharma 4.0: Digital Technologies Driving Smart Manufacturing (Nargund et al.) -- Part II: Manufacturing Aspects of Cell and Gene Therapy -- Chapter 12. Essential Aspects of Mesenchymal Stem Cell Manufacturing (Fleischhammer et al.) -- Chapter 13. Towards a Continuous Production of Human Mesenchymal Stromal Cells in a Chemically Defined Medium: Opportunities and Challenges for a Robust and Scalable Expansion Process (Tasto and Salzig) -- Chapter 14. Biomanufacturing Aspects of Gene Therapy (Warnock) -- Chapter 15. Manufacturing and Quality of Advanced Therapeutics: Cellular Therapies, CAR-T and Gene Therapies (van den Bos et al.). 330 $aThis volume ?Cell Engineerring 11 - Biopharmaceutical Manufacturing: Progress, Trends and Challenges? is a source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation. The book comprises contributions of experts from academia and industry active in the field of cell culture development for the production of recombinant proteins, cell therapy and gene therapy, with consideration of Digital Twin´s and facility design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. Inevitably, some omissions will occur in the test, but the authors have sought to avoid duplications by extensive cross-referencing to chapters in other volumes of this series and elsewhere. We hope the volume provides a useful compendium of techniques for scientists in industrial and research laboratories active in this field. 410 0$aCell Engineering,$x2542-9515 ;$v11 606 $aCytology 606 $aBiomedical engineering 606 $aBiotechnology 606 $aBiochemical engineering 606 $aPharmaceutical chemistry 606 $aVaccines$xBiotechnology 606 $aBiomaterials 606 $aCell Biology 606 $aBiomedical Engineering and Bioengineering 606 $aBiotechnology 606 $aBioprocess Engineering 606 $aPharmaceutics 606 $aBiomaterials-Vaccines 615 0$aCytology. 615 0$aBiomedical engineering. 615 0$aBiotechnology. 615 0$aBiochemical engineering. 615 0$aPharmaceutical chemistry. 615 0$aVaccines$xBiotechnology. 615 0$aBiomaterials. 615 14$aCell Biology. 615 24$aBiomedical Engineering and Bioengineering. 615 24$aBiotechnology. 615 24$aBioprocess Engineering. 615 24$aPharmaceutics. 615 24$aBiomaterials-Vaccines. 676 $a571.6 700 $aPörtner$b Ralf$01207271 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910800113003321 996 $aBiopharmaceutical Manufacturing$93876757 997 $aUNINA