Recipharm has opened a newly built GMP suite for clinical trial material (CTM) manufacture at its facility in Research Triangle Park, North Carolina, USA.
The suite, which represents a $750k investment, is intended to produce CTM for clinical studies up to Phase II for non-sterile dosage forms, including metered dose inhalers and semi-solid topical products. With the introduction of the GMP suite, Recipharm can now provide complete early development services from its facility in Research Triangle Park, including process development and scale-up, CTM manufacturing and packaging, product release and stability programs.
“At Recipharm, we are focused on managing complexity for our customers and this means providing a full service offering to simplify the supply chain. Bolstering our development business is a key priority and with this investment, we are now able to offer our customers in the US a broader range of services and help them take their projects to the clinical phase in an efficient way. The new suite also meets an industry-wide demand for cGMP manufacturing space for orally inhaled drug products,” says Ann Flodin, VP and General Manager of Recipharm’s facility in Research Triangle Park.
The new GMP suite is ISO 8 certified and includes a walk-in downflow booth. The facility has the capacity to produce metered dose inhalers in up to 25L batches and offers semi-solid production capabilities up to 20L.