GREENVILLE, N.C., Nov. 1, 2018 /PRNewswire/ — Metrics Contract Services (Metrics), a division of Mayne Pharma Group Limited, has added a Gerteis Mini-Pactor® roller compactor to its granulation capabilities at its new US$80 million oral solid dose commercial manufacturing facility in Greenville, North Carolina, USA. Metrics became a leader in dry granulation development and clinical manufacturing services after it purchased its initial Gerteis Mini-Pactor in 2014.
The Gerteis Mini-Pactor allows optimization within a range of press forces, roller speeds, and gap settings using knurled, smooth, toothed or custom rollers with a production output of up to 100kg/hr. These roller compactors will now be used for early phase formulation development, clinical trial production through to commercial manufacture.
In addition to the investment in dry granulation capabilities, the company’s recently opened manufacturing facility in Greenville includes newly purchased equipment from manufacturers such as Glatt, Thomas, O’Hara and IMA. Metrics is now able to offer clinical and commercial scale, solvent capable, fluid-bed processing and film coating, wet granulation, tableting, encapsulation, and pan-coating. The new facility more than quadruples the company’s capacity to manufacture oral solid dose pharmaceuticals products to well over 1 billion doses and increases significantly our capacity to manufacture potent compounds.
Metrics’ Executive Vice President Kimberly McClintock said, “With completion of our new commercial manufacturing facility and the success of our client’s clinical programs, it was time to add a second Gerteis roller compactor for use in commercial production. Based on the anticipated lot size and annual demand of the products progressing toward commercialization, the Mini-Pactor was the right choice for throughput and ease of tech transfer to commercial production. This supports our strategy to be a leading small molecule oral dosage form producer for targeted specialty medicines being developed today.”
To date, Metrics has supported over 20 clinical programs using the original Gerteis Mini-Pactor in the drug product manufacturing process. The first programs developed with the clinical Mini-Pactor are now progressing towards submission and commercialization.
About Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering 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 at www.metricscontractservices.com
About Mayne Pharma
Mayne Pharma is a specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX) focused on the application of drug delivery expertise to commercialize branded and generic pharmaceuticals, providing patients with access to better and more affordable medicines.
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 in Salisbury, Australia and Greenville, USA, with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and inherently unstable compounds. For further information, visit www.maynepharma.com.
Tom Salus, 1.252.707.6068, [email protected]
SOURCE Mayne Pharma
Source link Google News