Ask the Expert: Manufacturing Flexibility Is the Next Competitive Advantage

Q: Why is manufacturing flexibility becoming increasingly important for emerging biotechnology companies?

A: When people talk about manufacturing today, one of the biggest topics is capacity. We're seeing a big surge of companies adding capacity in the United States for a lot of the geopolitical reasons that have been going on. There are a lot of organizations building facilities to meet manufacturing needs here in the US.

The challenge is that these projects take time. It's not like you can start with a greenfield site and, in a year's time, have everything up and running. Because of that, we're seeing a need for what I would call filler capacity. While companies are waiting for their own facilities or other new sites to come online, they're looking for manufacturing capacity that already exists and is ready to go. That's really what we're seeing today when people talk about the capacity crunch.

At the same time, I think flexibility is the main thing, especially for emerging biotechnology companies. These organizations have a lot of unknowns. There are finance unknowns, there are unknowns around the success of their molecule, there are personnel unknowns, and there are so many things that can change as a company grows. Because of that, they're really looking for flexibility in their manufacturing partners.

I don't think flexibility is getting enough attention. We spend a lot of time talking about capacity, but not enough time talking about how contract manufacturing organizations can become more flexible to support companies whose needs are constantly evolving.

It is a bit of a dichotomy because, as manufacturers, we don't usually like flexibility. We like things to be very well planned out for years to come. Manufacturing depends on planning, scheduling, and meeting commitments. But I think we need to look at ourselves and find ways to become more flexible so we can help these emerging biotechs meet their manufacturing needs while still meeting our own commitments as organizations.

I also think it's important for companies to understand that not every manufacturing model is the same. At Novartis Contract Manufacturing, we're an embedded contract manufacturing organization. Novartis has more than 100 years of experience manufacturing medicines for patients, and we're able to offer excess manufacturing capacity to other pharmaceutical and biotechnology companies.

What makes our approach different is that it's the same people, the same quality systems, and the same regulatory processes that we use to manufacture Novartis medicines. We use those same teams and systems for our customers' medicines. There isn't an A team and a B team. It's all the same people, and we're incredibly proud of them because they really make the difference.

I think that's one of the biggest differentiators of our model, but more broadly, I think the industry has an opportunity to become more creative when it comes to flexibility. Emerging biotechnology companies don't always know exactly what they'll need a year from now, and their manufacturing partners have to recognize that reality.

As more companies move innovative therapies through development, manufacturing partnerships will continue to be important. Capacity matters, but I believe flexibility is going to matter just as much. Finding ways to provide that flexibility while maintaining quality and meeting organizational commitments is something our industry should continue talking about.