The new suite enables the contract development and manufacturing organization (CDMO) to provide complete early development services at the Research Triangle Park location. These services include process development and scale-up, CTM manufacturing and packaging, product release and stability programs.
Ann Flodin, VP and General Manager at Recipharm Laboratories, explained the facility supports the manufacture of different non-sterile dosage forms, such as metered dose inhalers, semi-solids, and dry powder capsules.
“With this location being Recipharm’s center of excellence for orally inhaled and nasal drug products, and with an experienced research team in place, this is a natural development for the company, extending the capabilities of Recipharm group,” Flodin told Outsourcing-Pharma.com.
The GMP suite is ISO 8 certified, features a walk-in downflow booth, and has the capacity to produce metered dose inhalers in up to 25L batches and offers semi-solid production capabilities up to 20L.
“We see the inhalation and semi-solid industries growing, and needing additional clinical trial manufacturing support," Flodin added.
"Also, the location is central in Research Triangle Park which is a rapidly growing science and technology cluster, with easy access for visitors through the nearby RDU airport.”