Process Intensification in the Manufacturing of Biotherapeutics

1st Edition, Volume 59 - July 5, 2022
Editors: Mattia Sponchioni, Davide Moscatelli
Language: English
Hardback ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 3 5 5 - 3
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 3 5 6 - 0

Process Intensification in the Manufacturing of Biotherapeutics, Volume 59 in the Advances in Chemical Engineering series, highlights new advances in the field with this new volu… Read more

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Process Intensification in the Manufacturing of Biotherapeutics, Volume 59 in the Advances in Chemical Engineering series, highlights new advances in the field with this new volume presenting interesting chapters on topics such as Evolution and design of continuous bioreactors for the production of biologics, Continuous countercurrent chromatography for the downstream processing of bioproducts: A focus on flow-through technologies Application of multicolumn countercurrent solvent gradient purification to the polishing of therapeutic proteins, Continuous precipitation technologies for the recovery of bioproducts, Continuous Recovery and Purification of Bioproducts on the Basis of Adsorption Technology, General Platform for Development of Integrated Continuous Downstream Processes, and more

Cover image
Title page
Table of Contents
Copyright
Contributors
Preface
Chapter One: Evolution and design of continuous bioreactors for the production of biological products
Abstract
1: Introduction
2: From batch to continuous
3: Production of monoclonal antibodies
4: Perfusion for intracellular products: Polyhydroxyalkanoates
5: Conclusions
References
Chapter Two: Continuous countercurrent chromatography for the downstream processing of bioproducts: A focus on flow-through technologies
Abstract
1: Introduction
2: Continuous countercurrent chromatography
3: Continuous countercurrent frontal chromatographic technologies
4: Conclusions
References
Chapter Three: Application of Multicolumn Countercurrent Solvent Gradient Purification to the polishing of therapeutic proteins
Abstract
1: Introduction
2: Production of therapeutic proteins
3: Relevant parameters for the evaluation of purification processes
4: Limitations of batch chromatography
5: Theory of Multicolumn Countercurrent Solvent Gradient Purification
6: Applications of MCSGP
7: Conclusions
References
Chapter Four: Potential of fluidized bed adsorption technology in continuous bioproduct recovery and purification
Abstract
1: Introduction
2: Liquid-solid fluidized bed technology
3: Biomass-adsorbent interactions
4: Continuous downstream processing with solid-liquid fluidized bed technology
5: Conclusions and future perspectives
References
Chapter Five: Smart platform for development of small-scale integrated continuous downstream processes
Abstract
1: Introduction
2: Orbit platform concept
3: Platform for integrated downstream process development
4: Small-scale continuous downstream processing
5: End-to-end production with continuous bioprocessing
6: Control of continuous downstream processes
7: Summary
Acknowledgments
References
Chapter Six: Fill-Finish: Large-scale manufacturing considerations
Abstract
1: Introduction
2: cGMP and pharmacopeia
3: Regulatory landscape
4: General considerations on the manufacturing plant for Fill-Finish operations of an aseptic filled sterile product
5: Fill-Finish process overview
6: Packaging materials
7: Cold chain
8: Future trends
References
Further reading
Index

Mattia Sponchioni

Mattia Sponchioni received his MSc cum laude in Chemical Engineering in 2015 and his PhD cum laude in Industrial Chemistry and Chemical Engineering in 2018, both at Politecnico di Milano. He is now working as a Research Associate at Politecnico di Milano, after having spent one year of Post-Doc at ETH Zürich. The main research interests of Mattia Sponchioni include the synthesis of thermo-responsive polymers and functional polymer nanoparticles for biomedical applications. During his career, Mattia gained expertise in the so-called controlled radical polymerization (CRP) techniques and in particular in the reversible addition-fragmentation chain transfer (RAFT) polymerization to impart highly controlled molecular architecture and chain length distribution to the polymers produced in his research. It is in this context that in 2017 Mattia spent six months as a visiting researcher at the University of Sheffield, in the group of Prof. Steven P. Armes, where he became expert in the RAFT-mediated polymerization-induced self-assembly (PISA) for the simultaneous synthesis of well-defined and amphiphilic block copolymers and their self-assembly into nanoparticles. Mattia Sponchioni is currently participant contact for the EU H2020 Marie-Curie innovative training network “Continuous Downstream Processing of Bioproducts” (https://www.researchgate.net/project/CODOBIO-Continuous-Downstream-Processing-of-Biologics) and teaching assistant of “Polymer Reaction Engineering” and “Applied Physical Chemistry” at Politecnico di Milano.

Affiliations and expertise

Research Associate, Politecnico di Milano, Italy

Davide Moscatelli

Davide Moscatelli received his Laurea cum laude in Chemical Engineering at the Politecnico di Milano in 2002, and his PhD in Chemical Engineering in 2006. He is full professor of Applied Physical Chemistry at Politecnico di Milano and he collaborates with ETH Zurich since 2007. His main research interests are in the material synthesis for technological applications, with particular emphasis on polymer materials, nanomaterials and chemical compounds for biomedical and oil&gas applications. The general aim of his research is the development of new approaches to synthesize and functionalize innovative, efficient, and tunable smart materials. Davide Moscatelli is co-author of more than 120 papers on international journals and more than 10 patents. H-index: 26. Davide Moscatelli serves as lecturer of Petroleum Technologies and Refining Processes course at Politecnico di Milano. Davide Moscatelli supervised more than 100 Bachelor thesis students in Chemical Engineering, more than 100 Master thesis students in Chemical Engineering and Material Engineering, and more than 10 PhD theses in Industrial Chemistry and Chemical Engineering. He is ViceDirector of the PhD course of Industrial Chemistry and Chemical Engineering at Politecnico di Milano (http://phd.chem.polimi.it/staff/) and, since 2017, he is Member of the Faculty Committee for the strategic plan Polimi2040 at Politecnico di Milano. Davide Moscatelli is a member of the editorial board and advisory panel of several international scientific journals. He is co-founder of Captive Systems srl, a spin-off company of Politecnico di Milano active in use of smart nanomaterials for wastewater treatments.

Affiliations and expertise

Full Professor, Politecnico di Milano, Italy