Almac Group services support first commercial orphan drug products
Amicus Therapeutics’ Galafold™, and Intercept Pharmaceuticals’ Ocaliva®, have received European and FDA approval, respectively.
“The partnerships with Amicus and Intercept both began at the drug product development stage and progressed through clinical trials onto commercialisation,” David Downey, VP of Commercial Operations, Almac Pharma Services, told Outsourcing-Pharma.com.
According to Downey, thekey differentiator of Almac from other services providers is the company’s ability to offer integrated solutions from development to commercialization from a single campus.
“For example rather than drug product crossing oceans for further processing (development, clinical or commercial), it literally just has to cross car parks,” he said.
Downey explained that Almac’s client partners benefit from a single project team assisting scientific continuity as their products progress through clinical trials and into commercialization.
“Both clients recognize and have benefited from Almac’s key value proposition,” he said. “Being virtual operations their management time is precious, so the ability to integrate services was crucial for them.”
Trends and demand
Recently, Almac has witnessed an increased growth in a number of areas, including drug products requiring specialist handling, processing including high potent molecules, and drug products with increased environmental sensitivity.
Downey added that there have been an increased number of drug products receiving orphan drug designation and fast tracking through development for commercial launch. Additionally, paediatric formulations of NCEs have resulted in an increase in the development and manufacture of Mini-tablet presentations, he told us.
“Over the next 5 years with the industry increasingly focusing on personalized medicines and discovering the next orphan drug breakthrough, we expect clients to need more bespoke solutions from processing smaller batch sizes, specialist packaging capabilities to temperature sensitive shipment of valuable drug products direct to the end-user,” explained Downey.
He also said that addressing counterfeiting will be a big industry challenge as pharma companies and service providers work to meet global regulatory track and trace requirements via serialisation.
