The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.
The UK contract manufacturing organisation (CMO) spoke to Outsourcing-pharma.com at CPhI, and said the observation was one driver behind its decision to invest in development-scale granulation and coating capacity at its facility in Nottingham.
The other, according to site manager Ian Lafferty, was the number of enquiries Aesica has received about capacity for high potency work at the site since it opened in May.
He said: “We’ve had a number of enquiries about more difficult capabilities, such as granulation and we’ve shown we can build an isolator around this equipment and still operate them.
“For instance, fluid bed coating and fluid bed granulation are dusty processes, and doing that with a HP compound causes even more issues than with capsule filling. Doing it inside the isolators makes those issues go away.”
A growing need
Lafferty told us that a lack of highly potent (HP) contractors for R&D (research and development) stems from an unwillingness to deal with toxic products because of old stigmas associated with workers using suits, rather than the safer isolator technology as found in the Nottingham facility.
He said issues like finding staff willing to work with the molecules, the extra investments associated with handling them, and even hesitance from sponsors who fear working in HP facilities have also led to a shortage of vendors.
However with a growing industry need for innovation, and many HP pipelines left untouched because companies cannot find suitable partners to manufacture products for R&D, Lafferty said the need for providers has never been greater.
“I do think this is a growing trend in the industry, but there are few places that offer the services. HP puts people off - it takes investment, and staff don’t want to work on it because of associated perception of danger,” he said.
He also said that for rare and orphan indications there is an opportunity for firms to work on the product commercially, as they need smaller – but higher value – batch sizes.