Executive Vice President, Metrics Contract Services
Metrics Contract Services and its parent, Mayne Pharma, are constructing an $80-million commercial pharmaceutical manufacturing facility as part of a site expansion in Greenville, North Carolina, outlined Kimberly McClintock, Executive Vice President, Metrics Contract Services, Mayne Pharma, at the DCAT Member Company Announcement Forum that was held on Monday March 20 at DCAT Week ’17. First production in the new building is scheduled for January 2018.
McClintock provided key highlights of the site expansion project that will involve greenfield construction of a 126,000-square-foot, oral-dose facility adjacent to the current facility and re-purposing of existing facilities to expand Metrics Contract Services’ analytical testing, formulation development, and clinical manufacturing capacity. The expansion also will include a new visitor and staff administration center linking the two main buildings and add a Stability Center of Excellence, which triples the company’s current stability capacity.
The new facility will house commercial manufacturing and packaging operations for Mayne Pharma’s branded and generic drug products as well as for customers of the Metrics Contract Services Division. Expanding Metrics’ offerings to include contract commercial manufacturing was a key driver in the investment decision, McClintock explained.The capital investment also was driven by a need to add specialized capabilities. It adds solvent-based, fluid-bed processing and film coating for Mayne Pharma operations in the United States. Mayne Pharma will triple its worldwide fluid-bed processing capacity when the facility opens. The new facility allows for the safe handling of highly potent products. Each of the 13 production suites features single-pass air and multiple strategically placed airlocks to direct process and product flows and to mitigate cross-contamination risks. Containment solutions are available for a wide array of unit operations. The facility maintains capabilities for US Drug Enforcement Administration Schedule II-IV drugs, including a large vault, and is pre-engineered to be expanded as needed to accommodate further growth.
Once commercial production activities transition out of the existing facility, it will be retrofitted to increase analytical, formulation and clinical manufacturing capacity. This re-purposing will add 10 processing rooms and expand laboratories. Strategic equipment additions will be made to complement commercial-scale equipment and to enable scale-up from concept through commercial at one location.
Complementing this new construction, Metrics Contract Services is investing $3.5 million in a stand-alone, 15,000-square-foot Stability Center of Excellence expansion that will triple current capacity. The expanded facility will be operational in April 2017 and includes automated emergency power generation to ensure the integrity of stored samples with system redundancies maintaining environmental controls. This investment was driven by the growth of Metrics’ analytical services and ensures capacity is available for increased registration batch stability programs associated with Metrics’ new commercial manufacturing offering.
With construction underway now, Mayne Pharma officials anticipate hiring up to 110 new scientists, quality assurance specialists, and other technicians to support expanded operations.