PREPARING THE WORKFORCE PIPELINE.

Biomanufacturing is a constantly evolving industry. And with rapid development comes a need for a highly trained and prepared workforce. State leaders met virtually to discuss the biggest changes they are seeing in the industry, how they are working to prepare the worker pipeline and what they are doing to adapt to developments around the COVID-19 pandemic.

Panelists:

Samuel M. Taylor, president, North Carolina Biosciences Organization (moderator)

John Balchunas, workforce director, National Institute for Innovation in Manufacturing Biopharmaceuticals, assistant director, Prof. Dev. Programs, Biomanufacturing Training & Education Center, North Carolina State University

Brent Harpham, executive director for BioNetwork and Life Sciences, N.C. Community College System

Rick Lawless, training manager, AveXis

Martin Meeson, president and CEO, FUJIFILM Diosynth Biotechnologies

Hernan Navarro, director, Biomanufacturing Research Institute and Technology Enterprise, N.C. Central University

Mike Renn, director, instructor, N.C. Pharmaceutical Services Network at Pitt Community College

Kimberly van Noort, senior vice president for academic affairs, chief academic officer, UNC System

Due to social distancing efforts, this month's round table took place via videoconference. The event was sponsored by BioNetwork, NCBIO, National Institute for Innovation in Manufacturing Biopharmaceuticals, Golden LEAF Biomanufacturing Training and Education Center, Pitt County Development Commission and AveXis. The transcript was edited for brevity and clarity.

HOW HAS THE PROCESS OF BIO MANUFACTURING CHANGED AT YOUR FACILITY OVER THE LAST FIVE TO SEVEN YEARS?

MEESON We've moved a lot more away from the traditional stainless-steel type of operation. [Previously,] there has been a lot of stainless steel, a lot of cleaning, and we've moved now to the more disposable systems.

We are predominantly, nearly totally, in the disposable systems for all of the small-scale cell culture antibodies, which in our case is 2,000L, that we make across the whole of the network, including this facility in North Carolina. That's been quite a big change, and something that's been mainly in the upstream. We've all heard of the single-use bioreactors, but we now have many more items in the downstream which are moving to single-use as well.

In our facility in Texas, we are almost exclusively single-use throughout the whole of the process, from the opening of the vial all the way through actually putting the drug substance in the bottle.

The other big [change] is around analytics. You know from your interactions with the [U.S. Food and Drug Administration] that one of the things they are extremely focused on is analytics, around the molecule when you go to get it registered.

We did an analysis the other day where we looked back over about 10 years, and virtually all of the equipment and some of the techniques that we're using today for analytics weren't even around 10 years ago.

BALCHUNAS When I looked back 10 to 15 years ago, "single-use" was a buzzword, and now it is a reality and very much the reality everywhere.

I think one area we are definitely seeing significant change is around the use of data analytics and automation, and it's a paradigm shift in ways. As companies begin leaning more heavily on data to make decisions, it impacts the workforce as a whole. It trickles all the way down to operators and technicians as a different cadre of person is needed to interface with that data to know how to react. As a result, companies are actively seeking out data analytics talent to build a more intellectually diverse workforce.

HOW HAS YOUR WORK FORCE ADAPTED TO NEW MANUFACTURING TECHNIQUES?

LAWLESS We are a gene therapy company. Our gene therapies treat genetic diseases such as spinal muscular atrophy, Rett Syndrome, genetic ALS. Other companies make products for hemophilia and Duchenne muscular dystrophy. Genetic diseases are caused by a mutation in a patient's DNA, so that they can't produce an important functional protein.

So many of the gene therapies use vectors, sometimes virus particles, to deliver good DNA to the target cells so that they can produce functional protein. Often, this requires only a single dose. So our product is basically DNA in a vector, which was a...