Bioprocessing of Viral Vaccines

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