Mayne Pharma has opened a new oral solid dose (OSD) commercial manufacturing facility in Greenville, North Carolina, US.
The company first announced its plans in August 2015, and a ground-breaking ceremony was held in September of the same year.
The $80m facility is designed to strengthen Mayne Pharma’s position in the oral drug delivery market by increasing its US oral solid dose manufacturing capacity to more than one billion doses a year. Its global fluid-bed processing capacity will also be increased. In addition, the expansion is expected to enhance the company’s mid to long-term growth potential to develop advanced drug-delivery technologies in the US.
Details of Mayne Pharma’s oral solid dose production facility
The new 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.
It also features 13 flexible production suites, which are 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 to filter out pollutants and particles. Multiple airlocks are provided for gowning, material and equipment.
The new facility also consolidates the company’s US distribution of Schedule II controlled products and a warehouse, which was previously located in Montgomery, Alabama.
Products manufactured at the new OSD facility
The new 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/bead coating capacity for modified-release bead/pellet drugs.
“The new OSD manufacturing facility is designed to safely handle and manufacture potent compounds.”
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-V controlled substances.
The company plans to introduce more than 20 products using the new facility, and increase processing capacity to 450kg per batch.
Equipment installed at the new OSD manufacturing facility
The new OSD commercial manufacturing 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 Wurster coater for solvent processing.
Retrofitting at Mayne Pharma’s existing plant in Greenville
Mayne Pharma’s former manufacturing facility was retrofitted to increase pre-commercial product development capacity to serve internal R&D purposes, as well as Metrics Contract Services (MCS) clients.
A total of 16 new 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 expansion 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.
Middough assisted Mayne Pharma in the development of the master site plan, as well as preliminary engineering and conceptual design.
Middough also provided support for the procurement of major equipment, selection of construction management contractor, and construction services.
BE&K Building Group was contracted to provide construction management services for the new facility.