CORPORATE PROFILE
Metrics Inc. is one of the most respected contract pharmaceutical development and manufacturing companies in the United States today.
Started in 1994 as an analytical laboratory, Metrics has evolved into a full-service provider of quality pharmaceutical formulation development; first-time-in-man (FTIM) formulations; clinical material manufacturing (CTM) for Phase I, II and III trials; commercial manufacturing; and analytical method development and validation services.
Metrics offers particular expertise in FTIM and Phase I, II, and III CTM manufacturing. The company has conducted more than 130 FTIM projects for different chemical entities in the last five years alone – while developing more than 700 batches of CTM in the same period.
Headquartered in Greenville, N.C., Metrics occupies a 93,000-square-foot Current Good Manufacturing Practices (cGMP) and Good Laboratory Practice (GLP) facility registered with and inspected by the U.S. Food and Drug Administration.
Metrics recently was ranked no. 21 on Business North Carolina magazine's "Mid-Market Fast 40" list, which showcases companies experiencing significant growth in revenues and employees within the last three years. The magazine noted that Metrics had experienced 25-percent revenue growth and 23-percent employee growth between 2008 and 2010.
Globally, Metrics provides a broad spectrum of contract services to support investigational new drug (IND), new drug (NDA) and abbreviated new drug (ANDA) submissions to regulatory agencies.
The Metrics Difference
Three critical differences set Metrics apart from other contract pharmaceutical development and manufacturing companies:
- 1. Clients work directly with a Metrics pharmaceutical or analytical development chemist. Our company does not employ non-scientist project managers to work as liaisons between clients and scientists.
- 2. Two, projects are expedited quickly and efficiently – they do not languish in an analytical development queue.
- 3. Three, Metrics' quality assurance team is highly experienced, ensuring compliance with all regulatory issues.
Services Offered
- Potent and cytotoxic. Our dedicated and segregated facility provides total engineered containment of all processes through customized hard-wall isolation technologies and achieves containment ~ 30 nanograms per cubic meter.
- Formulation. Our formulation scientists provide timely analyses and recommendations for finished dose formulations on insoluble actives, unstable actives, potent and toxic actives and small molecule delivery. Metrics provides seamless scale up to commercial manufacture in batch sizes ranging from < 1 kg to 400 kg. Our expertise in final formulation included immediate release, sustained release, tablets and capsules, coated tablets, fast dissolve, chewable tablets, capsule filling, over-encapsulation, enteric coating, matrix release and bi-layer tablets.
- Manufacturing. Our large-scale manufacturing facility has a production capability of 1 billion tablets per year with two packaging lines, two granulating rooms and three compressing rooms, including high-speed tablet presses. Our facility is equipped to handle DEA Schedule II through V compounds.
- Analytical. Metrics provides expert analytical method development and validation on a wide range of testing equipment for API and finished dose forms, as well as compendial testing (USP/NF, JP, BP, EP, ACS) of material. We handle all complex and poorly soluble compound types including potent, toxic, light- and temperature-sensitive, and DEA-regulated.
- Stability Storage. Metrics is renowned for developing and validating stability-indicating methods and has state-of-the-art chamber systems that meet ICH and USP guidelines. Metrics can customize storage conditions as needed.
- Microbiology. We offer antibiotic assay and sterility testing, as well as full microbiological support of sterile and non-sterile products. Our scientists routinely perform sterility testing, bacterial endotoxin and particulate matter testing on parenterals. In addition, Metrics frequently works with unique drug products that require non-traditional handling and testing, and provides referee lab testing, water activity testing and autoclave validation support.
