True Concept to Commercialization is Here with the Addition of Commercial Manufacturing at Metrics
Long recognized as a highly reputable partner for small molecule, oral solid dose development, clinical materials manufacturing, and analytical laboratory testing, Metrics Contract Services has expanded its service offerings to include contract manufacturing.
We have the competence, flexibility and facilities to handle challenging projects that require custom processes and solutions. We offer turn-key services including full testing, regulatory support, supply chain support, packaging, stability, CMC support and serialization. Efficient transfer from clinical phase production is assured with our commercial manufacturing scale equipment. Our capabilities comply with the highest regulatory and health standards.
Our Commercial Manufacturing (CMO) services include:
- Full product development, manufacturing and testing support for Phase I, II, and III clinical trials
- Production of Immediate and modified Release oral solid dosage forms (consult our equipment list for details.)
- Production of registration and process validation batches
- Commercial batch sizes ranging from 50-450 kg.
Experience matters. We offer “concept to commercialization” by employing the same quality systems, quality oversight and manufacturing expertise that has enabled over a decade of successful commercial manufacturing with a stellar track record of regulatory compliance. Our clients range from small pharmaceutical companies to global leaders in the pharmaceutical industry – with projects ranging from the simple to the complex.
Whatever the project scope, our teams will work diligently to complete your project according to your specifications and bring a superior quality product to market.
Our capabilities include:
- A dedicated account management group to ensure scope, forecasting, scheduling, and delivery of products
- The technical transfer of products into a world-class manufacturing facility by an experienced technical services group
- Support from experienced commercial quality assurance, operations, quality control, supply chain, and warehousing departments
- Designed to mitigate cross contamination risks by enforcing rigid control of flows of personnel, materials and equipment, interlocked airlocks, and 100% outside air in processing rooms
- A 126,000-square-foot facility with 16 manufacturing suites
- An estimated annual production capacity of 1-2 billion oral solid dose units (combined tablet and capsule production)
- Compliance with U.S. FDA and other international regulatory agencies
Our equipment capabilities (see our equipment list for details):
- Bin blending for direct blend manufacturing
- Dry granulation by roller compaction
- High-shear granulation – multiple units including integration with fluid bed drying
- Fluid bed processing – drying, top spray granulation, Wurster processing (both aqueous and organic solvent capable processing)
- Tablet compression
- Tablet coating using a perforated coating pan (both aqueous and organic solvent capable pan coating processing)
- Encapsulation: powders and beads
- Tray drying ovens
- High-speed bottle packaging lines compliant with today’s serialization requirements
To learn more about our commercial manufacturing services or to discuss a potential partnership with Metrics Contract Services, please contact us today.