Mayne Pharma’s U.S. GMP accredited facility is located in Greenville, North Carolina. The state-of-the-art, facility totalling nearly 12,000 m2 (126,000 sq ft) facility was officially opened in April 2018 and leverages best-in-class containment design to meet or exceed the quality and safety standards of major drug regulatory authorities.
The new Greenville facility more than quadruples the company’s U.S. capacity to manufacture oral solid-dose pharmaceutical products to well over 1 billion doses and introduces significant capacity to manufacture potent compounds and new capability to manufacture modified-release bead/pellet products.
The facility enables Metrics Contract Services – Mayne Pharma’s contract development division – to offer development clients a comprehensive “concept to commercialisation” 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.
Specifically designed for containment, the new facility can readily manage the commercial scale manufacturing of potent compounds — a key growth area for pharma companies today as they develop increasingly complex drugs for the treatment of cancer and chronic diseases. Each of the 13 production suites in the new facility was engineered to meet today’s stringent manufacturing demands with a best-in-class approach to mitigating cross contamination — while also offering flexible space and delivering a broad range of capabilities and services.
Here are some “fast facts” about the new commercial manufacturing facility:
- Construction began in August 2015
- US$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 Contract Services 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