Developing An Accelerated And More Cost-Effective Single-Use Adenoviral Vector Vaccine Manufacturing Process Through Public-Private Collaboration

By Jenner Institute, Oxford University, UK: Sofiya Fedosyuk, Thomas Merritt, Marco Polo Perata-Alvarez, Phillip Angel Manning, Adam J Richie and Alexander D Douglas; Merck KGaA, Darmstadt, Germany: Ada Lam, Nicolas Laroudie, Anilkumar Kangokar, Josselyn Haas, Anders Jonsson, Alex Xenopoulos, Youness Cherradi and Anissa Boumlic

Beginning with Edward Jenner’s breakthrough method to protect against smallpox in the 1790s, vaccines have saved and improved millions of lives around the world. UNICEF touts immunization as one of the most cost-effective public health interventions to date, averting an estimated 2 to 3 million deaths every year. Yet while remarkable progress has been made in eradicating devastating diseases such as smallpox and polio, the global population remains at risk due to difficulties accessing vaccines, shortages in supply, slow responses to outbreaks and pandemics and the presence of emerging pathogens. Nearly twenty million children under one year of age worldwide did not receive the recommended doses of diphtheria, tetanus and pertussis vaccine (DTP) in 2017, and a similar number of children failed to receive a single dose of the measles vaccine.

In addition to these well-known pathogens, emerging and re-emerging diseases continue to pose a challenge. Consider the World Health Organization’s priority list of infectious diseases for which R&D efforts are needed to enhance our preparedness. Among the top ten is the ominously named “Disease X” – a placeholder for a yet-to-be-identified potential disaster, and emphasizing the need for platform technologies which can be rapidly adapted to respond to any pathogen, without prior knowledge.

We believe that public-private collaboration is essential to drive development of much needed, new approaches to vaccine manufacturing that enable both speed to market and process optimization. In this whitepaper, we describe our collaboration with the Jenner Institute, Oxford University in the United Kingdom to develop an optimized, single-use GMP process for manufacturing adenoviral vector-based vaccines. Founded in 2005, the Jenner Institute is a partnership between the University of Oxford and the Pirbright Institute and is a successor to the former Edward Jenner Institute for Vaccine Research.