Metrics Contract Services is a full-service
pharmaceutical development and manufacturing organization serving clients
worldwide. We deliver proven scientific and operational excellence for oral
dosage forms. Today, as a subsidiary of Mayne Pharma Group, we offer clients
more resources and capabilities than ever before.
We offer comprehensive formulation development services from
pre-clinical through Phase III CTM including: tableting, immediate release, modified
release (including controlled/matrix and sustained release), capsule filling,
over-encapsulation, 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 more than 100 chemists on staff, Metrics analyzes
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
Our segregated potent facility provides total engineered
containment through customized, hard-wall isolation technologies. 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
independent entry, exit and equipment double airlocks, decontamination showers,
dedicated wash-room, dedicated equipment storage and pass through for
First-Time-In-Man (FTIM) Studies
Metrics Contract Services has successfully 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 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.
Phase I, II, III
Our CTM capabilities offer capacity for all clinical
trial phases. Our state-of-the-art, flexible manufacturing facility and
equipment can handle up to 450-kilo batch sizes. We also offer expertise in
over-encapsulation for comparator studies, as well as potent drug handling
capabilities. CTM packaging is also available.
Metrics Contract Services is investing $3.5 million in a
15,000-sq-ft stability storage expansion that will triple its current capacity.
The expanded stability storage facility is being constructed with automated
emergency power generation to ensure integrity of stored samples, with system
redundancies maintaining environmental controls in all circumstances.
The parent company of Metrics Contract Services, Mayne Pharma, is
investing $80 million to significantly expand facilities and equipment at its
site in Greenville, NC. The strategic capital investment will fund a new
126,000-sq-ft, oral-dose commercial manufacturing facility, quadrupling the
company’s US manufacturing capacity, and the re-purposing of space to create
10+ new analytical laboratories and formulation development suites.
The new facility means Metrics Contract Services can offer a more
complete “concept to commercialization” solution in one contiguous location for
clients, providing larger scale and increased capabilities for seamless
scale-up, eliminating the need for site transfers.
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