07.11.17
Mayne Pharma and its contract pharmaceutical development and manufacturing organization, Metrics Contract Services, have designated their new stability storage facility in Greenville, NC a “Center of Excellence.” According to John Ross, president of Mayne Pharma USA, the $3.5 million facility earned the classification by integrating best-in-class operational standards and equipment during construction.
The 17,000 sq.-ft. CoE triples the company’s previous stability storage capacity and is fully validated and operational. “This world-class facility will allow Mayne Pharma and Metrics Contract Services to readily meet the needs of our clients’ stability storage projects today and well into the future,” Mr. Ross said.
The stability storage facility features back-up power generation, integrated system redundancies for HVAC, chillers and humidifiers, and specialty ICH climatic mapping and tolerances for temperature and humidity. Also, three stability chambers offer available shelving capacity of 900 sq.-ft. One chamber has available shelving capacity of 1,530 sq.-ft., and one chamber has capacity of 6,444 sq.-ft.
Mayne Pharma chose to partner with Weiss Technik North America for high-quality, GMP-compatible and FDA-compliant stability testing solutions. Relying on environmental simulation technology, Weiss Technik stability storage systems are customized for specific users and employ energy efficiency standards. Weiss Technik is accredited with ISO 9001:2008, and its stability storage systems meet ICH Guidelines Q1A for Stability Testing and Q1B for Photostability Testing. They also comply with guidelines established by the U.S. FDA, the World Health Organization and the EMA’s Committee for Proprietary Medicinal Products.
“If we were to lose any aspect of our system, we would be operational right away,” Mr. Ross said. “We have invested more than most companies in stability storage to ensure the continuous integrity of our clients’ products.”
The need for the Stability CoE was driven by growth across all of Mayne Pharma’s businesses, including Metrics Contract Services. With the addition of commercial manufacturing to its portfolio, Metrics has seen an increase in late-phase and registration-batch stability programs, which support various international markets.
Mayne Pharma is also investing $80 million to repurpose existing capacity and add new facilities and equipment for its pre-commercial analytical labs and clinical manufacturing capacity for Metrics. The 126,000-sq.-ft. facility now under construction expands commercial-scale manufacturing capability to include multi-particulate layering and bead-coating fluid bed technology, as well as significantly increased capacity for manufacturing highly potent products.
The 17,000 sq.-ft. CoE triples the company’s previous stability storage capacity and is fully validated and operational. “This world-class facility will allow Mayne Pharma and Metrics Contract Services to readily meet the needs of our clients’ stability storage projects today and well into the future,” Mr. Ross said.
The stability storage facility features back-up power generation, integrated system redundancies for HVAC, chillers and humidifiers, and specialty ICH climatic mapping and tolerances for temperature and humidity. Also, three stability chambers offer available shelving capacity of 900 sq.-ft. One chamber has available shelving capacity of 1,530 sq.-ft., and one chamber has capacity of 6,444 sq.-ft.
Mayne Pharma chose to partner with Weiss Technik North America for high-quality, GMP-compatible and FDA-compliant stability testing solutions. Relying on environmental simulation technology, Weiss Technik stability storage systems are customized for specific users and employ energy efficiency standards. Weiss Technik is accredited with ISO 9001:2008, and its stability storage systems meet ICH Guidelines Q1A for Stability Testing and Q1B for Photostability Testing. They also comply with guidelines established by the U.S. FDA, the World Health Organization and the EMA’s Committee for Proprietary Medicinal Products.
“If we were to lose any aspect of our system, we would be operational right away,” Mr. Ross said. “We have invested more than most companies in stability storage to ensure the continuous integrity of our clients’ products.”
The need for the Stability CoE was driven by growth across all of Mayne Pharma’s businesses, including Metrics Contract Services. With the addition of commercial manufacturing to its portfolio, Metrics has seen an increase in late-phase and registration-batch stability programs, which support various international markets.
Mayne Pharma is also investing $80 million to repurpose existing capacity and add new facilities and equipment for its pre-commercial analytical labs and clinical manufacturing capacity for Metrics. The 126,000-sq.-ft. facility now under construction expands commercial-scale manufacturing capability to include multi-particulate layering and bead-coating fluid bed technology, as well as significantly increased capacity for manufacturing highly potent products.
