Recipharm Opens GMP Suite for Clinical Trial Materials

Recipharm has opened a newly built GMP suite for clinical trial material (CTM) manufacture at its facility in Research Triangle Park, NC.

The suite, which represents a $750,000 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, the contract development and manufacturing organization (CDMO) 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," said Ann Flodin, vice president and general manager of Recipharm’s facility in Research Triangle Park. "Bolstering our development business is a key priority and with this investment, we are now able to offer our customers in the U.S. 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."

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 25-liter batches and offers semi-solid production capabilities up to 20-liters.