Greenville Site Expansion
Mayne Pharma Inc., of which Metrics Contracting Services is a division, has invested more than $80 million developing facilities and equipment at its Greenville, N.C., site. These investments include:
Commercial Manufacturing Facility
Custom-designed from the ground up and under construction for two years, our new 126,000-square-foot facility leverages best-in-class containment to meet or exceed quality and safety standards of major drug regulatory authorities.
The facility more than quadruples our capacity to manufacture oral solid-dose products in the United States to more than 1 billion doses annually.
With this facility, we also introduce commercial-scale, solvent-capable, fluid-bed processing and film coating — a first for our operations in the United States.
Specifically designed for containment, our facility can readily manage the commercial-scale manufacturing of potent compounds — a key growth area for clients today. Each of the 13 production suites was engineered to meet stringent demands for mitigating cross contamination, while also offering flexible space and delivering a broad range of capabilities and services. Features include:
- Single-pass air and multiple distinct and strategically placed airlocks for gowning, material and equipment.
- Segregated product corridors.
- 100-percent HEPA-in and HEPA-out filtered air.
- Dedicated quality control laboratories.
- Commercial scale up to 450kg per batch.
The facility allows Metrics — Mayne Pharma’s contract development division — to offer clients a comprehensive “concept to commercialization” solution under one FDA site registration. Space constraints in our former manufacturing facility precluded Metrics from broadly offering commercial manufacturing services to its clients.
Pre-Commercial Pharmaceutical Development Facility
Now that commercial manufacturing has been consolidated within a new facility, Mayne Pharma is repurposing its former manufacturing facility to expand pre-commercial capacity to better service Metrics Contract Services clients. This repurposing includes creating 10+ new processing rooms and expanded laboratories — nearly doubling the existing footprint of Metrics.
Stability Center of Excellence
Mayne Pharma recently opened a $3-million, 17,000-square-foot stand-alone Stability Center of Excellence in Greenville. Features that establish the stability storage facility as best in class include:
- 100-percent back-up power generation providing 1,200 kilowatts of electricity, fueled by an uninterrupted supply of natural gas.
- Integrated system redundancies for HVAC, chillers and humidifiers.
- 100-percent seamless and sealed construction inside and outside units.
- Specialty climatic mapping and tolerances that include each International Conference on Harmonisation (ICH) stability zone for temperature and humidity.
- Sufficient square footage to double the number of chambers initially installed, providing room to grow for years.
Systems used in the center meet ICH Guidelines Q1A for Stability Testing and Q1B for Photostability Testing, and comply with guidelines established by the FDA, the WHO and the European Medicines Agency’s Committee for Proprietary Medicinal Products.