January 16, 2012
The Daily Reflector
Metrics Inc. is now offering neat active pharmaceutical ingredient (API) capsule filling in its state-of-the-art potent and cytotoxic facility.
The Greenville-based company secured for its potent facility a Capsugel Xcelodose system a precise powder micro-doser and automated encapsulator that places API directly into capsules with a high level of accuracy. Metrics then installed a custom-built isolation system for the equipment, achieving total containment at levels approximating 30 nanograms per cubic meter of room air.
This new capability means Metrics now offers clients with potent and cytotoxic drugs another avenue toward Phase I first-time-in-man (FTIM) clinical trials.
“Clearly there’s still a great deal of debate within the pharmaceutical industry about the value of neat API dosing and what role formulation can or should play when bringing new medicines to trial or market,” Joe Cascone, director of potent pharmaceutical development, said. “At Metrics, we want to offer each client an individualized solution that works best for their specific product. Making neat API dosing available to clients with potent and cytotoxic products is one more way we can do that.”
The active-only, powder-in-capsule approach has become increasingly popular, mainly because it’s faster — allowing companies to get prospective new drugs into clinical trials more quickly.
Metrics’ potent facility is unique within the contract pharmaceutical development and manufacturing industry for how it provides total engineered containment of all processes through customized hard-wall isolation technologies. Its two processing rooms come complete with independent entry double airlocks, independent decontamination showers and exit airlocks, independent equipment airlocks, and access to a dedicated washroom. It is designed for one-way flow of material, personnel and equipment.
The facility’s dedicated air handler brings in 100 percent outside air with HEPA-in and HEPA outfiltering at the rate of 11,000 cubic feet per minute and 25 air changes per hour. There are pass-throughs for the export of product and waste, as well as dedicated equipment storage.
The company increased its capacity to safely work with more potent APIs by reducing exposure to 30 nanograms per cubic meter. Thanks to these measures, Metrics eliminated the need for powered air purifying respirators. And after every campaign, Metrics employees conduct comprehensive health-based cleaning verification of shared surface areas.
Started as an analytical laboratory in 1994, Metrics has evolved into a full-service provider of quality pharmaceutical formulation development; FTIM formulations; clinical material manufacturing (CTM) for Phase I, II and III trials; commercial manufacturing; and analytical method development and validation services.
Headquartered in Greenville, N.C., Metrics has particular expertise in FTIM and Phase I, II, and III CTM manufacturing. The company has conducted more than 120 FTIM projects for different chemical entities in the last five years alone – while developing more than 700 batches of CTM in the same period.