Mayne Pharma, an Australian pharmaceutical company, and its contract pharmaceutical development and manufacturing organization, Metrics Contract Services, have designated their new $3.5-million, 17,000-square foot facility stability storage facility in Greenville, North Carolina as a Center of Excellence (CoE).

The CoE triples the company’s previous stability storage capacity. The center is fully validated and operational.

The facility contains 100% back-up power generation providing 1,200 kilowatts of electricity, fueled by an uninterrupted supply of natural gas and sealed construction inside and outside the units.

There are also integrated system redundancies for HVAC (heating, ventilation and air conditioning), chillers, and humidifiers as well as specialty climatic mapping and tolerances that include stability zones as per International Conference on Harmonization guidelines for temperature and humidity.

Included in the facility are three stability chambers with available shelving capacity of 900 square feet each; one chamber with available shelving capacity of 1,530 square feet; and one chamber with available shelving capacity of 6,444 square feet.

The Stability Center of Excellence is part of planned expansions at the Mayne Pharma site in Greenville. Mayne Pharma is investing $80 million to repurpose existing capacity and to add new facilities and equipment by doubling pre-commercial analytical labs and clinical manufacturing capacity. The 126,000-square-foot facility now under construction expands commercial-scale manufacturing capability to include multi-particulate layering and bead-coating fluid-bed technology as well as increased capacity for manufacturing highly potent products.

Source: Metrics Contract Services