Pharma firms explore converting facilities for cross-sector drug production

Shared standards enable repurposing of sites but cost and safety remain hurdles.

Can existing pharmaceutical facilities be converted to accommodate production of medicines for either human or animal use? Experts say the trend is gaining traction globally as firms look to maximise existing assets and speed up time to market.

Stephanie Ledwidge, Associate, Life Sciences, Southeast Asia, Linesight, explained that the overlap in standards helps ease conversion. “Both types of facilities will follow GMP standards. So you're likely starting with solid foundation when it comes to things like contamination control, clean room classifications and your validated equipment, but the real work begins when you dig into the product specific needs,” she said.

In animal health, Ledwidge noted, there is “a bigger emphasis on high volume, cost efficient manufacturing,” which can require different batch sizes, equipment setups, and material handling. Moving from animal to human production, however, raises the bar. “You're likely going to need to tighten things up so that can mean more stringent sterility controls, traceability measures, upgrades to meet stricter documentation and validation requirements,” she said.

Gordon Nicholson, Regional Director, IPS, agreed that core structures often require little modification. “Physically, we don't really need to do any major changes, as most of the time, the facilities are designed in a similar approach,” he said. The bigger focus, he added, is on equipment choices, such as “single use equipment so that we're not creating any cross contamination,” as well as decontaminating spaces when production switches between sectors.

Nicholson pointed to regulatory complexity and pandemic-driven concerns as major hurdles. “There's different regulators for humans and animals, although there are a lot of similarities between them. Those different regulations sometimes have some different requirements, but pretty much we can make them match or align to the higher standard,” he said. “But probably more importantly is the concerns over cross contamination between species, and we've seen that in pandemic situations”

For Ledwidge, the greatest value comes in markets like Singapore where space is costly. “The real strength of cross functionality lies in adaptability… This enables faster responses to market changes, greater capital efficiency, better use of existing assets, and this is key in an industry where speed to market is critical,” she said.

Nicholson added that high-value equipment such as filling lines also make cross-sector use compelling. “The filling lines themselves are extremely expensive facilities to build and to operate. So high utilisation of those spaces is very helpful for manufacturers,” he said.