Catalent rethinks stainless for new bio plant

We checked in with Kent Payne, Catalent VP/GM for development and clinical services, after hearing about the CDMO's plans for a bioprocessing plant reliant on single-use technology. The Madison, WI, plant, which will quadruple space and replace bioprocess operations in nearby Middleton, will specialize in cell-line engineering and production of Phase I and II substances, as we reported.

FiercePharma Manufacturing: Was disposable technology difficult to sell up the line?

Payne: It was not trivial, especially in this case. We had already purchased similar-scale stainless steel trains. So our decision involved walking away from that several-million-dollar investment. We had to do some deep thinking.

Three years ago, the decision would have been more difficult. But there's now more robust data on single-use bioreactors. We've come a long way with leachables and extractables, for example. And we're already beyond the 1,000 liters that seemed unachievable a few years ago.

FPM: What did you do with the stainless steel equipment?

Payne: We used a broker to put out feelers, then sold it to a company that's still linked to the older technology.

FPM: How did single-use technology win out over workhorse stainless steel?

Payne: We've wanted to move in this direction. Single-use bioreactors have greater flexibility, particularly for cleaning and change-over. The flexibility is important to us, especially at the clinical manufacturing stage where we work on many different proteins from different clients.  

Our Middleton facility has two GMP suites with 200-liter stainless steel bioreactor trains. We're beginning construction on three GMP suites that will have single-use bioreactors from 50 to 1,000 liters.

FPM:  Why build a new plant, rather than renovate and expand?

Payne: Three main reasons: Demand for cell-line engineering, facility age and bioprocess constraints.

Work involving our gene-expression technology more than doubled during the 2010 fiscal year, and we're still seeing 20% increases year over year.

The Middleton plant was appropriate in the early 2000s when this business was starting up. Now we need more space, higher ceilings and robust infrastructure for larger scale reactors. We also want to optimize unidirectional process flow to improve throughput in each line.

FPM: How will you handle the changeover to the new technology once the Madison facility is up and running next year?

Payne: We've already installed in the Middleton facility one of the single-use systems intended for Madison.  Staff members have logged significant hours of hands-on experience.