So, You're Building A Cell Therapy Facility: A Choose Your Own Adventure Story

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

It’s as timeless a tale as Cinderella and her glass slipper:

A C&G company is born.

It’s gung-ho manufacturing executives have lofty ambitions that CDMOs are perhaps ill-equipped to handle from a capacity, talent, and/or experience side of things, especially in the nascent cell and gene therapy industry.

Given the quick pace of the science, the desperate need of the patients, and the company’s desire to keep that manufacturing know-how (and IP) in-house, the company makes the bold decision to invest in its own facility.

The press releases arrive, first announcing the new facility, and, eventually, celebrating the triumphant opening of this long-awaited facility. The company’s manufacturing destiny has been secured and everyone is thrilled. (In the fairy tale, this is when the prince and princess ride off into the sunset to live happily ever after.)

This is where the “build” story often ends. But in an industry that is as unique and in-flux as the cell and gene therapy space is today, “happily ever after” just doesn’t cut it. What about the “messier” bits that are inevitably going to arise post-sunset?

I watched an Endpoints News webinar entitled, “Strategies For Building A Cell Therapy Manufacturing Facility.” The webinar, which included executives from Tenaya Therapeutics, Iovance, Kite Pharma, and Instil Bio, provided some great considerations and best practices for those of you who have chosen to take the plunge into building your own capacity. Because the C&G space is a wild adventure, to say the least, I wanted to share these experts’ insights in a less traditional way: via a (very simple) “choose your own adventure” series of articles. The adventures, which are based on the broader questions you may have about building a new facility, are linked below.  

Enjoy your journey beyond the sunset with your sexy single-use equipment.   

The Scenario: You’ve left the shiny boardroom table. You’ve won over the executives and the investors; you’ve eaten the cake; you’re still drinking the champagne. You’re going to build your own cell therapy manufacturing facility! Congratulations!

But as the champagne bubbles hit your tongue, the question rears its ugly head: What now?

What specifically are you thinking about? Pick one:

• SOS: Where do I even start?
• What does a “make-to-order” model mean for my manufacturing facility?
• How do we manage manufacturing talent as our company grows?
• How do we know if and when the time is right for expansion?
• What do we need to be striving for in the future to innovate while also controlling COGS?