Metrics Expands with Fast-track Product Development Laboratory
March 3, 2014
The Daily Reflector
Metrics Inc. is making significant investments in its facilities and equipment for the benefit of contract services clients by opening a new laboratory to better support fast-track development of pharmaceutical products.
Also in its Greenville facility, the company is adding to its equipment portfolio a Gerteis Mini-Pactor, a high-pressure-precise roller compactor that provides Metrics’ formulation development scientists even greater flexibility in batch sizes and throughput.
The fast-track development laboratory and Gerteis Mini-Pactor represent continuing investment efforts at Metrics to support the changing needs of its contract services clients, said Stefan Cross, president of Mayne Pharma USA, the parent company of Metrics.
The new $1.6 million, 4,524-square-foot lab provides maximum flexibility for early formulation and analytical method development.
The facility is designed for pre-clinical development of early formulation prototypes and related analytical methods. In this laboratory setting, formulators and chemists will have significant autonomy to conduct development activities more quickly, according to Dr. Brad Gold, vice president of pharmaceutical development.
Segregated from the main Metrics operations and containing fully dedicated equipment, these new processing suites have independent HVAC systems and state-of-the-art engineering controls such as interlocking airlock doors, room air pressure differentials, high-volume room air turnover, and 100-percent HEPA air filtration.
“These suites offer our scientists tremendous flexibility, which will support the fast-track development of drug products,” Gold said. “Prototype formulations and methods developed in this lab will be transferred to the adjacent facility for further development and manufacture of clinical trial materials and registration batches. There, they will be manufactured under the exacting auspices of current good manufacturing practice so that Metrics will continue to deliver proven scientific and operational excellence in oral solid dosage forms.”
The ground floor of the new facility consists of five processing rooms and one analytical laboratory. The second floor consists of workstations, office space and a conference room. This project increases to 16 the number of processing rooms, which are in addition to the extensive analytical laboratories and large-scale manufacturing and packaging operations that Metrics has available.
Housed within Metrics’ main facility, the company’s new Gerteis Mini-Pactor has capacity ranging from 10 grams for pilot projects to 100 kilograms per hour for small-scale production, making it especially useful in a formulation development laboratory setting, Gold said.
“While big pharma companies may already be familiar with this particular roller compactor, Metrics can be considered an early adopter among pharmaceutical contract development and manufacturing organizations,” he said. “This equipment investment reflects Metrics’ ongoing commitment to operational excellence and to conducting science that is most meaningful to our clients and the patients we collectively serve.”
Metrics Inc. is a full-service global pharmaceutical development and manufacturing organization serving clients worldwide. The company’s areas of expertise include quality pharmaceutical formulation development; first-time-in-man (FTIM) formulations; clinical trial materials (CTM) manufacturing for Phase I, II and III trials; and analytical method development and validation services leading to commercial scale manufacturing.
Metrics’ capabilities include highly potent, cytotoxic and unstable compounds, Schedule II-V controlled substances, and products with poor bioequivalence.
Metrics operates as a subsidiary of Mayne Pharma Group Limited.