Oral solid dose (OSD) manufacturing facility
Australian pharmaceutical company Mayne Pharma has opened an oral solid dose (OSD) commercial manufacturing facility in Greenville, North Carolina.
The company first announced its plans for the facility in August 2015. A ground-breaking ceremony for the facility was held in September that year.
The $80m facility is designed to strengthen Mayne Pharma’s position in the oral drug delivery market by increasing its oral solid dose manufacturing capacity in the US to more than one billion doses a year. The facility will also increase the company’s global fluid-bed processing capacity.
The expansion is also expected to enhance the company’s mid to long-term growth potential for developing advanced drug-delivery technologies in the US.
The oral solid dose manufacturing facility was built on a 126,000ft² greenfield site owned by Mayne Pharma. It houses both commercial manufacturing and packaging operations for the company’s generic and branded drug products.
The facility also features 13 flexible production suites, engineered to deliver a wide range of capabilities while reducing the risk of cross-contamination.
High-efficiency particulate arresting (HEPA) air filters with single-pass filtration are installed at the facility to filter out pollutants and particles. Multiple airlocks are provided for gowning, material and equipment.
The facility also consolidates the company’s US distribution of Schedule II-controlled products and a warehouse, which was previously located in Montgomery, Alabama.
The OSD manufacturing facility is designed to safely handle and manufacture potent compounds. It also adds commercial-scale, solvent-based fluid-bed processing technology, multi-particulate layering and bead coating capacity for modified-release bead and pellet drugs.
The facility also supports Mayne Pharma’s pipeline of products, including highly potent and cytotoxic products, drugs with poor bioavailability, and Drug Enforcement Administration (DEA) approved Schedule II to V-controlled substances.
The company plans to introduce more than 20 products using the facility and increase its processing capacity to 450kg for each batch.
The facility is equipped with a solvent-capable Thomas Flex 500 perforated pan tablet coater, a Glatt VG Pro 44 high-shear mixer for wet granulation, and a Glatt GPCG Pro 120 fluid-bed dryer with a Wurster coater for solvent processing.
Mayne Pharma’s former manufacturing facility was retrofitted to increase pre-commercial product development capacity to serve internal R&D purposes, as well as clients of Metrics Contract Services (MCS), a division of Mayne Pharma.
A total of 16 processing rooms were created to increase the analytical and formulation development. Dedicated quality control laboratories were also added for use by MCS.
The retrofitting of the existing facility allowed MCS to offer both immediate release and advanced oral drug delivery technologies and expand the company’s clinical trials manufacturing services.
A new visitor and staff administration centre, with connections to both the new and existing buildings, was built as part of the expansion.
The centre houses teleconference rooms, workstations, employee development and training classrooms, as well as visitor meeting rooms, an employee fitness facility and a cafeteria with a seating capacity of 350.
Mayne Pharma’s Greenville facility was supported by $2.7m in funding and tax incentives from the Governments of North Carolina and economic development agencies. The facility was also supported by a performance-based grant of $550,000 from the One North Carolina Fund.
US-based consultant Middough assisted Mayne Pharma in developing the master site plan, as well as the preliminary engineering and conceptual design.
Middough also provided support for the procurement of major equipment, selection of construction management contractor, and construction services.
American construction company BE&K Building Group was contracted to provide construction management services for the new facility.
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