coronavirus vaccine

Coronavirus vaccines? Kulkarni and Boulanger weigh in on lofty goals

May 20, 2020

Can pharma meet its lofty goals for coronavirus vaccine production?

Pharma companies have been in a mad dash to meet the world’s expectation of producing a coronavirus vaccine.

Of course, there are massive hurdles ahead. If history is any indicator, many of these vaccines will ultimately fail. And even if a candidate is approved, the greater imminent challenge of scaling up production remains.

Can the pharma industry quickly make enough vaccines to put an ultimate end to the pandemic? CRB’s Niranjan Kulkarni, Ph.D. and Rob Boulanger, Ph.D. discuss the topic in a Pharma Manufacturing article, “Coronavirus vaccines: The billion dose dash.”

Boulanger asks the industry to explore flexible options:

“What they would target with a typical pandemic, like influenza, is making 50 million doses at a plant within six months facilities that mass produce cGMP mRNA vaccines. To design, build and validate a new plant…you’re talking two years. And we don’t have that kind of time. But to convert? Assuming it’s a perfect scenario…you probably need six months.”

To get a sense of the average capacity at a vaccine production facility, Boulanger says it’s useful to look at the pandemic response plan that was put in place by the Biomedical Advanced Research and Development Authority (BARDA), to leverage existing facility space.

Although far-reaching plans, such as the one being proposed by the Gates Foundation, don’t specify whether new facilities would be built, or if production lines in existing plants would be retrofitted to accommodate a coronavirus vaccine, Boulanger says that converting facilities is the much faster way to go.

As Boulanger points out, however, converting an existing facility is no trivial task:

“It’s going to take several months to acquire the raw materials to make a new vaccine. Almost all of these products have very specialized raw materials…any one of these could have a long lead time. So you’d want to be on the phone with whoever makes your growth media, for example, to secure a supply.”

A challenge Kulkarni points out is that bringing a newer type of vaccine to scale, such as mRNA, provides its own unique challenges, even though the technology exists to manufacture them.

If changing equipment or process, you need to requalify your equipment and validate the process changes. That takes time.

Companies will also need to eye solutions for expanding fill-finish capacity. Kulkarni explains:

“Depending on the customization and automation needed, procuring, installing and running filling equipment can go all the way up to two years in lead time. So you need to find facilities with the right technology tailored to what you’re filling.”

Read the full article here.