6. The Manufacturing Scale-Up Challenge

The Vax Files

In this sixth episode, experts discuss how vaccine development complexities often boil down to the manufacturing process and scaling up to large quantities. We take a look at how manufacturing processes are set up including the use of contract manufacturers (CMOs or CDMOs) that are largely in control of different parts of the production line. Experts also discuss the various pros and cons for the different manufacturing processes of mRNA vaccines, adenoviral vector vaccines, protein subunit vaccines and inactivated vaccines, and where bottle necks and supply delays could potentially form if stakeholders are not on their game. Ancillary material like vials and syringes will also be an important consideration when supply and demand is still unclear given that a lot of promising vaccines are not yet authorized. At the end of the day, nothing is impossible in this world filled with experienced industry players, but cooperation and collaboration might be the ultimate secret ingredient to success. Expert Guests:

-- Dr Michael Kurilla is the Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, US National Institute of Health. He has been a member of the advisory committee for vaccines and related biologics since 2018.

-- Dr Craig Laferriere is a consultant on vaccine design and manufacturing with over 25 years experience in vaccine manufacturing, design and licensing. He is the head of vaccine development at Novateur and has previously worked on vaccine development for GlaxoSmithKline and Pfizer.

-- Dr Prashant Yadav is a Senior Fellow at the Center for Global Development and Affiliate Professor of Technology and Operations Management at INSEAD. Yadav has with governments and global organizations to improve medical product supply chains. Previous roles include Strategy Leader-Supply Chain at the Bill & Melinda Gates Foundation and Chair of the Market Dynamics Advisory Group of the Global Fund.

associate editor of PharmSource, a trade publication that exclusively covers the pharmaceutical manufacturing industry.