The development and use of vaccines can be credited with saving many millions of lives. The processes by which vaccines are developed, approved, and commercially manufactured are wide-ranging, complex, and come with specific considerations. The development of novel types of vaccines often requires new, dedicated manufacturing facilities and complicated scale-up procedures.
This book aims to be a complete reference guide to vaccine production, from laboratory to approval. It is comprehensive in scope, with chapters prepared by expert contributors from academia and the pharmaceutical and biotechnology industries. Chapter 1 delves into the history of vaccine process development, setting the scene and providing an overview of the different types of vaccines currently available or under development, giving real-world examples and process considerations.
Further chapters look in more detail at production platforms, such as yeast expression systems, plasmid DNA, novel expression systems and viruses; and at processes such as purification and conjugation. Downstream steps, such as stabilisation, formulation, excipient choice, and lyophilisation are discussed in detail. The reader will gain an understanding of the current state of the art and future prospects for vaccine production. Two chapters are dedicated to providing useful, practical guides to completing the US Biologics License Application (Common Technical Document Format) and the Investigational New Drug Application for vaccine products. The final two chapters examine facility design and vaccine production economics. Each chapter is properly introduced with a background to the topic.
There are detailed descriptions of the technologies used for vaccine development; challenges and issues are discussed. Colour figures illustrate key points and the use of process flow diagrams is particularly useful when manufacturing procedures are described. The text is also supported by a number of useful tables (note that in e-book format some table formatting may be lost). This book is for those with a specific interest in vaccine manufacture, including development scientists, manufacturing scientists, and quality personnel. This will be particularly useful for those setting up facilities for vaccine production.
‘Vaccine Development and Manufacturing’, edited by Emily P Wen, Ronald Ellis, Narahari S Pujar. Pp 464, price £100, ebook £80.99. New Jersey: Wiley-Blackwell; 2014. ISBN 978 0 470 26194 1