Single-use technology will see more HP production brought in-house but contract manufacturers will still win-out, according to Alkermes.
The firm believes as much as 25 per cent of the new products currently coming out of pipelines are high potent (HP), and predicts that percentage will grow more in coming years.
Toxic compound developers have a tendency to outsource large scale manufacturing to save on the cost of building new high containment facilities, the company added, but with the advent of single-use tech more firms could bring production back in-house.
Manufacturing director Kevin Brady told us “I certainly think the advancements in new technologies, particularly single-use, over the last number of years have been quite significant,” he said. “Obviously as the containment technologies improve they may want to bring some of that capability back in house.”
Nevertheless, Brady believes outsourcing for HP compounds will remain the emergent trend.
“There is a competence associated with the manufacture of HP products and some companies just don’t want to maintain that competence. It’s not their niche, so they will still look to outsource into the future.”
Big Pharma are the big players
Senior VP of operations Jim Botkin told us he expects the biggest portion of contracts will come from Big Pharma, which already takes up the biggest chunk of business because adding the extra manufacturing capabilities required for HP products is “against their current strategy for operations”.
He added: “I think they have the larger research efforts and they’re the ones who have the ability to take the compound and find out whether it has any pharmacological activity.
“The smaller companies would have less HP in their pipeline,” as they are often less equipt – “even in early development” – to handle high potencies.
And with the trend for more HP active pharmaceutical ingredients (APIs), Botkin believes outsourcing to high containment experts will grow and as such said toxic compounds will be a growing focus for Alkermes – particularly amongst larger customers.
In recent months several other contract manufacturing organisations (CMOs) and service providers have expanded their HP production capacilities.
In August Bend Research launched it’s new HP spray drying facility , this month Aesica ramped-up its potent capabilities in the face of “industry demands”, and next year Wales-based Penn Pharma will become the latest provider to offer high containment services when it opens its new facility.
When asked why the HP market is growing so rapidly, Brady said “growth in areas of oncology treatment, which primarily requires HP APIs, seems to be an emerging space.” He said that with new entities becoming increasingly difficult to develop people are also now looking to HP where they may not have previously.
Botkin added that a growth in the hormones and steroidal markets – which require self-containment – is also a key driver.