Metrics Contract Services is investing $3.5 million in a 15,000-square-foot stability storage expansion that will triple its current capacity.
The investment is being driven by the growth of clients’ registration batch stability programs in support of various international markets. The company’s expanding portfolio of clients who have successfully brought drug products to commercialization also requires additional stability storage support, said John S. Ross, executive vice president.
“As a full-service, global drug development and manufacturing organization, Metrics is committed to ensuring we adequately support client’s needs throughout their product’s life cycle, and providing sufficient, reliable stability services is one way we do that,” he said. “Our goal is to become the oral-dose ‘concept to commercialization’ CDMO of choice for pharma companies, and our larger stability storage capacity represents part of that commitment to meet client needs.”
Stability storage provides specific environmental conditions for drug substance and drug products meeting International Conference on Harmonisation (ICH) standards. Metrics’ stability chambers are fully validated to meet strict temperature, humidity and uniformity controls. Rooms and chambers are continuously monitored to comply with ICH standards as well as current Good Manufacturing Practices (cGMP).
Metrics’ expanded stability storage facility is being constructed with automated emergency power generation to ensure integrity of stored samples. System redundancies mean environmental controls remain in place in chambers should a primary conditioner go down.
The $3.5-million stability storage facility is part of planned expansions at the Greenville campus. The parent company of Metrics, Mayne Pharma, is investing $80 million to significantly expand facilities and equipment, including 10-plus new analytical labs and formulation development suites. Metrics also will introduce commercial-scale manufacturing capability including multi-particulate layering, bead-coating fluid bed technology and significantly increased capacity to manufacture highly potent products.
The expanded and improved facilities include engineered solutions to support the handling of potent compounds and to mitigate cross-contamination risks, along with an industry-leading design to meet the various requirements of international regulatory agencies.
Metrics and Mayne Pharma have committed to hiring 110 new scientists, quality assurance specialists and other technicians to support expanded operations, increasing their U.S. workforce by more than a third.