Mayne Pharma, a Salisbury South, Australia-headquartered pharmaceutical company reports that it and its contract development and manufacturing business, Metrics Contract Services, have opened a new $80-million, oral solid-dose commercial manufacturing facility in Greenville, North Carolina.

Mayne Pharma’s new 126,000-square-foot facility more than quadruples the company’s capacity to manufacture oral solid-dose pharmaceutical products in the US to over 1 billion doses and introduces capacity to manufacture potent compounds and new capability to manufacture modified-release bead/pellet products.

With this new facility, Mayne Pharma introduces commercial-scale, solvent-capable, fluid-bed processing and film coating — a first for its operations in the US, according to the company. Fluid-bed processing (also called multi-particulate or bead coating) applies polymers to an active pharmaceutical ingredient. Using this drug-delivery technology, scientists can modify how a drug is released after ingestion, such as delaying or sustaining its release to reduce side effects or make the drug more effective, according to information from Mayne Pharma.

Specifically designed for containment, the new facility can manage the commercial-scale manufacturing of potent compounds. Each of the 13 production suites in the new facility was engineered to meet manufacturing demands for mitigating cross contamination while also offering flexible space and delivering a range of capabilities and services. Key features include: (1) single-pass air and multiple distinct and strategically placed airlocks for gowning, material, and equipment; (2) segregated product corridors; (3) 100% HEPA-in and HEPA-out filtered air; (4) dedicated quality control laboratories; and (5) commercial scale up to 450 kg per batch.

While commercial manufacturing is a new offering for Metrics Contract Services, it is not a new capability for the Mayne Pharma team at the Greenville site, according to the company. The Greenville site has tested, manufactured, and packaged commercial products for more than 10 years, according to Mayne Pharma. Space constraints in the former manufacturing facility precluded Metrics Contract Services from offering commercial manufacturing services.

Now that commercial manufacturing has been consolidated within the new facility, Mayne Pharma’s former manufacturing facility in Greenville will be repurposed during the next two years to expand pre-commercial product development capacity to serve both internal research and development and Metrics Contract Services clients. The repurposing includes the creation of 10+ new processing rooms and expanded laboratories.

Source: Mayne Pharma