From concept to commercialization: Metrics delivers across the spectrum
METRICS CONTRACT SERVICES OFFERS ‘SNEAK PEAK’ AT NEW $80-MILLION ORAL SOLID-DOSE
COMMERCIAL MANUFACTURING FACILITY
With the added capacity of this new 126,000-square-foot facility, Metrics Contract Services will offer development clients “concept to commercialization” solutions in one contiguous location under one site registration.
Construction of Mayne Pharma’s new oral solid-dose commercial manufacturing facility in Greenville, N.C., is complete, with production beginning in January. This $80-million, 126,000-square-foot facility quadruples the company’s U.S. manufacturing capacity.
The facility positions Metrics Contract Services to offer development clients a comprehensive “concept to commercialization” solution in one contiguous location under one site registration — delivering larger scale and increased capabilities for seamless scale-up, and reducing the technical and regulatory complexity of site transfers.
Metrics is the contract development and manufacturing division of Mayne Pharma.
A key highlight of this expansion is Mayne Pharma’s commercial-scale, solvent-based, fluid-bed processing and film coating — a first for its operations in the United States. With the commissioning of this facility, Mayne Pharma will triple its worldwide fluid-bed processing capacity.
While commercial manufacturing will be a new offering for development clients, it is not a new capability for the Mayne Pharma team or the Greenville site, which has successfully tested, manufactured and packaged commercial products for more than 10 years. Space constraints in the current manufacturing facility precluded Metrics from offering commercial manufacturing broadly to its clients.
Here are some “fast facts” about the new commercial manufacturing facility:
- Construction began in August 2015
- First production scheduled for January 2018
- $80 million invested in new construction, new equipment and renovation
- Facility is 126,000 square feet in size
- Engineered from ground up to maximize flexible space and segregate flows of people, equipment and materials
- 13 new production suites, each featuring 100-percent HEPA-filtered outside air plus multiple airlocks to support potent handling and mitigate cross-contamination
- Annual production will increase to 1 billion+ doses
- Offers clients full “concept to commercialization”— from first-time-in-man to commercial manufacturing at one contiguous location under one FDA site registration
- Key pieces of equipment include:
- Solvent-capable Glatt GPCG Pro 120 fluid-bed dryer with integrated high-sheer granulator
- Glatt VG Pro 440 high-speed mixer for wet granulation
- Solvent-capable Thomas Flex 500 batch tablet coater
- IMA Adapta 100 high-speed capsule filler with 100-percent inline weight checking
- Sejong SM-300 high-speed mixer and wet granulator
- Fette 3090i and Fette 2200i tablet presses
- Bosch 1500S capsule filler and Qualicaps CWI-80 capsule checkweigher
- Fitzpatrick Chilsonator L-83 roller compactor
- O’Hara Technologies DD400 tray dryer
Metrics is a full-service contract development and manufacturing organization that has delivered scientific and operational excellence for oral dosage forms to clients worldwide for more than 20 years.
Areas of expertise include:
- Pharmaceutical formulation and process development
- First-time-in-man formulations
- Phase I-III clinical trial materials manufacturing and bottling
- Phase-appropriate analytical method development and validation services
Technical capabilities include:
- Potent and unstable compounds
- Solvent-based, fluid-bed processing and film coating
- Schedule II-V controlled substances
- Formulation solutions to enhance bioavailability
Products manufactured include:
- Tablets, including coated, bilayer and modified release
- Powder and bead-filled capsules and minitabs
- Advanced pellet formulations for immediate, sustained, pulsed and delayed release
For more information about the new facility and what it means for you and your projects, contact our sales team.