This book focuses on cell culture-produced viral vaccines to meet the needs of the rapidly expanding research and development in academia and industry in the field. This book introduces the basic principles of vaccination and the manufacturing of viral vaccines. Bioprocessing of Viral Vaccines, will provide an overview of the advanced strategies needed to respond to the challenges of new and established viral infection diseases. The first few chapters cover the basics of virology and immunology as essential concepts to understand the function and design of viral vaccines. The core of the content is dedicated to process development, including upstream processing and cell culture of viral vaccines, downstream processing, and extensive analytical technologies specific to viral vaccines. Advanced process analytical technologies (PAT) and Quality by Design (QbD) concepts are also introduced in the context of vaccine manufacturing. The case studies included cover inactivated, attenuated vaccines exemplified by influenza vaccines, sub-unit vaccines exemplified by Virus Like Particles (VLPs: HPV vaccines) and sub-unit vaccines (Flublock), vectored vaccines: adenoviruses and Vesicular stomatitis Virus (VSV) vectored vaccines, genomic vaccines (DNA and mRNA) vaccines as developed for COVID-19 response in particular and a review of COVID-19 vaccines approved or in advanced clinical trials. This book is aimed at graduate engineers and professionals in the fields of vaccinology, bioprocessing, and biomanufacturing of viral vaccines.
Contents
Editors ......................................................................................................................vii
List of abbreviations.................................................................................................ix
Chapter 1 Bioprocessing of viral vaccines–Introduction ................................1
Amine Kamen and Laura Cervera
Chapter 2 Introduction to virology..................................................................17
Shantoshini Dash
Chapter 3 Introduction to basic immunology and vaccine design ..............35
Alaka Mullick and Shantoshini Dash
Chapter 4 Cell lines for vaccine production...................................................57
Isabelle Knott, Jean-Philippe Matheise, Isabelle Ernest, and Jean-Pol Cassart
Chapter 5 Upstream processing for viral vaccines–General aspects...........79
Lars Pelz, Sven Göbel, Karim Jaen, Udo Reichl, and Yvonne Genzel
Chapter 6 Upstream processing for viral vaccines-Process
intensification .................................................................................137
Sven Göbel, Lars Pelz, Udo Reichl, and Yvonne Genzel
Chapter 7 Downstream processing of viral-based vaccines........................175
Rita P. Fernandes, Cristina Peixoto, and Piergiuseppe Nestola
Chapter 8 Analytics and virus production processes ..................................201
Emma Petiot
Chapter 9 Manufacturing of seasonal and pandemic influenza
vaccines–A case study ...................................................................225
Cristina A. T. Silva, Shantoshini Dash, and Amine Kamen
Chapter 10 Recombinant vaccines: Gag-based VLPs ...................................239
Laura Cervera, Irene González-Domínguez, Jesús Lavado-García, and Francesc Gòdia
Chapter 11 Vectored vaccines ..........................................................................269
Zeyu Yang, Kumar Subramaniam, and Amine Kamen
Chapter 12 Design and production of vaccines against COVID-19
using established vaccine platforms ............................................293
Ryan Kligman, Jesús Lavado-García, and Amine Kamen
Index......................................................................................................................315
Biography
Amine Kamen is a professor of bioengineering at McGill University, and Canada
Research Chair in bioprocessing of viral vaccines. He is a researcher emeritus of the
National Research Council of Canada (NRC) where he was employed until early
2014, as head of the Process Development section of the Human Health Therapeutics
Portfolio. At NRC, he established one of North America’s largest and most advanced
governmental centers for animal cell culture addressing process development and
scale-up of biologics. Also, he developed with his team and licensed to industry
multiple technology platforms for efficient manufacturing of recombinant proteins
and viral vectors and vaccines and led technology transfer to manufacturing sites for
clinical evaluation and commercialization. His current research activities focus on
uncovering mechanisms associated with cell production of viral vectors and viral
vaccines, cell and metabolic engineering, process control and monitoring, and process
analytical technologies of high-yield productions of viral vectors for gene delivery
and vaccination. He has published over 170 papers in refereed international journals
and acts as a consultant for several national and international private and public
organizations.
Laura Cervera is a Chemical Engineer from Universitat Autònoma de Barcelona
(Barcelona, Spain). After graduating she did her PhD in Biotechnology on the topic
“Strategies for improving production levels of HIV-1 VLPs by transient transfection
of HEK 293 suspension cultures”. Then she moved to McGillUniversity (Montreal,
Canada) to pursue her research on VLP production, this time using Insect cells as a
platform. She came back to Barcelona to join a project on AAV production for gene
therapy applications using HEK 293 cells.
