Tablets Capsules

TC0620

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32 | Solid Dosage Sourcebook 2020 Metrics Contract Services Who We Are Metrics Contract Services is a cus- tomer-focused, full-service global contract development and man- ufacturing organization (CDMO) specializing in novel oral dosage forms providing pharmaceutical development, analytical testing, and commercial manufacturing services to over 100 clients worldwide. We offer a complete "concept to com- mercialization" solution under one FDA site registration. For those needing commercial manufactur- ing services, we deliver seamless scale-up, eliminating the need for costly and time-consuming site transfers. Additionally, we have a comprehensive project manage- ment process to streamline and ensure our processes are efficient as possible. With an invigorated focus on our dynamic industry, we invite you to learn why we're stronger by any metric. Areas of Expertise Pharmaceutical Development and Clinical Trial Materials Manufacturing We offer comprehensive formulation development services from preclini- cal through Phase III CTM including: tableting, immediate release, mod- ified release (including controlled/ matrix and sustained release), capsule filling, milling, micronizing, enteric coating, spray drying, extrusion, and spheronization. Our facilities and processes are designed to handle potent products, cytotoxic com- pounds, and controlled substances. Analytical Services With more than 140 chemists on staff, Metrics analyzes the physi- cal and chemical characteristics of drug substances and drug products through development and valida- tion of methods, release and stability testing. We perform this work in com- pliance with industry standards and international regulatory guidelines. Potent Products Our potent facilities provide total engineered containment through customized, hardwall isolation tech- nologies. Containment is achieved at 30 nanograms per cubic meter of room air; equipment and change parts are dedicated exclusively to potent use. The facility features inde- pendent entry, exit and equipment double airlocks, decontamination showers, dedicated washroom, ded- icated equipment storage and pass through for product/waste. Fast Track First Time In Man (FTIM) Studies Metrics Contract Services has suc- cessfully delivered materials for over 150 FTIM studies. Our process ensures speed and quality, with a 16-24 week timeline from receipt of well-characterized NCE to ship- ment to the clinic. Services include stability studies, analytical methods development and validation. Choose simple formulation, blended powder in capsule, or neat API in a bottle. Concept to Commercialization Two years ago the parent com- pany of Metrics Contract Services, Mayne Pharma, invested $80 million to significantly expand facilities and equipment at its site in Green- ville, NC. The result was a new 126,000 sq. ft. oral dose commercial manufacturing facility. The facil- ity quadrupled the company's US manufacturing capacity, and the repurposing of existing space created 10+ new analytical laboratories and formulation development suites. The new facility means Metrics Contract Services can offer a more complete concept to commercial- ization solution in one contiguous location for clients, providing larger scale and increased capabilities for seamless scale-up, eliminating the need for site transfers. Metrics Contract Services 1240 Sugg Parkway Greenville, NC 27834 Tel: 252-752-3800 Fax: 252-758-8522 thomas.salus@maynepharma.com www.metricscontractservices.com

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