Greenville, NC, August 26, 2016 --(PR.com
)-- Metrics Contract Services is investing $3.5 million in a 15,000-square-foot stability storage expansion that will triple its current capacity.
The facility, scheduled to open spring 2017, will feature large, walk-in chambers with state-of-the-art controls, system redundancies and back-up power supply.
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.
About Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide. We deliver proven scientific and operational excellence for oral dosage forms.
Metrics’ areas of expertise include quality pharmaceutical formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing.
Technical capabilities include highly potent, cytotoxic and unstable compounds; Schedule II-V controlled substances; and products with poor bioequivalence, for which we offer an impressive proprietary portfolio of advanced delivery methods. Located in Greenville, N.C., Metrics is a proud member of Mayne Pharma. Learn more online.
About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange. The company develops and manufactures branded and generic products globally – either directly or through distribution partners – while applying its drug-delivery expertise for contract development and manufacturing services.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that have been marketed around the world.
Mayne Pharma has two drug development and manufacturing facilities based in Salisbury, Australia, and Greenville, N.C., USA, with expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds.