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Biopharmaceutical Manufacturing

Progress, Trends and Challenges

  • Book
  • © 2023

Overview

  • Comprehensive review of manufacturing aspects for biopharmaceuticals, including cell and gene therapy
  • Brings together the knowledge and experience of leading international experts from academia and industry
  • Provides broad understanding of related problems and solutions for students, scientists, and people in industry

Part of the book series: Cell Engineering (CEEN, volume 11)

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Table of contents (15 chapters)

  1. Manufacturing of Recombinant Therapeutic Proteins

  2. Manufacturing Aspects of Cell and Gene Therapy

Keywords

About this book

This 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.

Editors and Affiliations

  • Institute of Bioprocess and Biosystems Engineering, Hamburg University of Technology, Hamburg, Germany

    Ralf Pörtner

About the editor

​Prof. Dr.-Ing. Ralf Pörtner: Senior research associate and group leader at Hamburg University of Technology, Institute of Bioprocess and Biosystems Engineering and Honorary Professor at TH Mittelhessen University of Applied Sciences, Giessen. The main research interests of Prof. Pörtner are development and optimization of bioreactor techniques and process strategies, in particular for cell cultures and microbial reactions, including model-based control concepts, and tissue engineering. He has in total published about 150 peer-reviewed papers.

Bibliographic Information

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