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Stability Storage Facility Q&A

Stability Storage Facility Q&A

Metrics Contract Services recently announced it is investing $3.5 million to build a dedicated, 15,000-square-foot stability storage facility that will triple the organization’s current storage capacity. In a Q & A, Executive Vice President John S. Ross discusses the new facility and what it means to the organization.

Q. Can you describe the new stability storage facility being built at Metrics?

A. The 15,000-square-foot, standalone facility, which is scheduled to open next spring, will feature large, walk-in chambers with state-of-the-art controls, system redundancies and back-up power supply. The new facility will triple our current stability storage capacity.

Q. What’s driving the need to build this new facility now?

A. Our investment is being driven by the growth of clients’ registration batch stability programs, which, in turn, have grown as the result of various international regulatory agencies’ requirements. We also have an expanding portfolio of clients who have successfully brought drug products to commercialization, which also requires additional stability storage support.

Q. Does stability storage represent a significant part of the work Metrics does?

A. It’s definitely an important part of the work we do. As a full-service, global drug development and manufacturing organization, Metrics is dedicated to ensuring that we adequately support our clients and their needs throughout the life cycle of their products, and providing sufficient, reliable stability storage is one way we do that. Our vision at Metrics is to become the oral dose ‘concept to commercialization’ CDMO of choice for pharma companies, and our larger stability storage capacity will help us fulfill that vision.

Q. What role does stability storage play in the life cycle of a drug product?

A. Stability storage provides specific environmental conditions for drug substance and drug products in order for them to meet International Conference on Harmonisation (ICH) standards. The stability storage chambers at Metrics are fully validated to meet strict temperature, humidity and uniformity controls. Our rooms and chambers are continuously monitored to comply with ICH standards as well as current Good Manufacturing Practices (cGMP). The new facility is being constructed with automated emergency power generation to ensure the integrity of stored samples, with system redundancies ensuring environmental controls remain in place in chambers even if a primary conditioner goes down.

Q. The new stability storage facility at Metrics is part of a larger expansion effort, correct?

A. That’s correct. It’s one of a number of planned expansions occurring at our site in Greenville, N.C. The parent company of Metrics, Mayne Pharma, is investing $80 million to significantly expand facilities and equipment, which includes adding 10-plus new analytical labs and formulation development suites. Metrics also will introduce commercial-scale manufacturing capability — including multi-particulate layering and bead-coating fluid bed technology — and significantly increase our capacity to manufacture highly potent products. We’re especially excited about our expanded potent facility, which incorporates engineered solutions to support the handling of potent compounds and the mitigation of cross-contamination risks, as well as an industry-leading design to meet the various requirements of international regulatory agencies.

Q. Do all of these expansions extend to the employee base at Metrics?

A. Metrics and Mayne Pharma have committed to hiring 110 new scientists, quality assurance specialists and other technicians to support expanded operations.

Thought-Leader Information:
Name: John S. Ross
Title: Executive Vice President
Company Name: Metrics Contract Services