Metrics Contract Services is a science-led, full-service global contract development and manufacturing organization (CDMO) specializing in novel oral dosage forms and providing pharmaceutical development, analytical testing, and commercial manufacturing services to over 100 clients worldwide. We’re proud to offer a complete “concept to commercialization” solution under one FDA site registration. For those needing commercial manufacturing services, we deliver seamless scale-up, eliminating the need for costly and time-consuming site transfers. Additionally, we have a comprehensive project management process to streamline and ensure our execution is efficient as possible. A division of Mayne Pharma, we’re serious about science and sharply focused on novel drugs that make a difference.
Pharmaceutical Development and Clinical Trial Materials Manufacturing
Our Pharmaceutical Development team of veteran formulation scientists delivers materials for all phases of clinical development through to commercial manufacturing. Those comprehensive formulation development services range from preclinical through Phase III CTM including: tableting, immediate release, modified 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 compounds, and controlled substances.
With over 150 analytical chemists dedicated to solving complex challenges, Metrics provides a full range of method development and validation services as well as routine testing in state-of-the-art laboratories. We analyze the physical and chemical characteristics of drug substances and drug products through development and validation of methods, release and stability testing. We perform this work in compliance with industry standards and international regulatory guidelines.
Our potent facilities provide engineered containment through customized, hardwall isolation technologies. Containment is achieved at 30 nanograms per cubic meter of room air. Contained equipment and change parts are dedicated exclusively to potent use. The facility features independent entry, exit and equipment double airlocks, decontamination showers, dedicated washroom, dedicated equipment storage and pass through for product/waste.
Fast Track First-Time-In-Human Studies
Metrics Contract Services has successfully delivered materials for over 150 FTIH studies. Our process ensures speed and quality, with a 16-24 week timeline from receipt of well-characterized NCE to shipment 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
We have invested over $100 million dollars in our Greenville, NC site in the past five years. The most significant component of that investment is our new commercial manufacturing operation, which is 126,000 square feet of oral solid dose manufacturing capability specializing in high potency throughout. This facility enables Metrics Contract Services to offer solutions from initial concept to global commercialization in one contiguous location for clients, providing seamless scale-up and eliminating the need for site transfers.
Posted Date: 12/3/2020
This record has been viewed 1156 times.