TONY D’AMORE^*, YAN-PING YANG
*Corresponding author
Sanofi Pasteur, Toronto, Ontario, Canada

Abstract

Vaccination has made the greatest contribution to global health of any human intervention apart from the introduction of clean water and sanitation. Despite the successes, approximately 6.6 million children still die each year and about a half of these deaths could be prevented by vaccination. The COVID-19 pandemic has pushed the vaccine industry right to the forefront. The expectation has never been this high to come up with innovative solutions to fight this terrible disease and to develop an effective vaccine in an unprecedented time frame. Over the last several decades there has been a significant evolution in breakthroughs in bioprocess technologies to support vaccine development. The advances in these technologies have greatly benefited vaccine development and manufacturing to achieve consistent product purity and quality, in a timely and cost- effective manner. This article reviews the constraints and complexities in the vaccine industry, specifically in vaccine product development and manufacture; and describes the current trends in bioprocess development and manufacturing innovation and technologies to overcome these challenges, with an outlook into the future.

CHALLENGES, COMPLEXITIES AND PROMISES

Vaccination has made an enormous contribution to global health. Global coverage of vaccination against many important infectious diseases of childhood has been enhanced dramatically since the creation of WHO’s Expanded Programme of Immunization in 1974 and of the Global Alliance for Vaccination and Immunization in 2000 (1).

The global vaccine market has been rapidly growing and as a result has been attracting interest and new players. WHO (2) has reported that from 2000 to 2013 the vaccine market has significantly grown (Table 1). Market trends suggest that by 2028 the value of the vaccine market is estimated to be approximately $100 billion USD, growing at a CAGR (Compound annual growth rate) of 11.02% (3,4). Furthermore, there are more than 120 new products in the development pipeline of which 60 are of importance for developing countries.  Vaccines are, therefore, becoming the growth engine for the pharmaceutical industry (2).  The COVID-19 pandemic has pushed the vaccine industry right to the forefront ...