where it starts. The project manager stays with
that project – even as it transfers into com-
mercial manufacturing – in order to maintain
consistency with the client. “The thing that the
client likes is that the technical lead is always
the same person in case there are any ques-
tions,” says Basham. “This person is intimately
involved with all aspects of the product life cy-
cle. This system is a differentiator for us.”
For clinical trial manufacturing (CTM),
Metrics offers 12 GMP manufacturing suites,
including five suites for potent actives (OEL
at or above 1mcg/m3 room air). It offers two
additional suites for highly potent actives, with
100% contained equipment (OEL at or above 30ng/m3 room air).
Three packaging lines complement the aforementioned manufacturing
suites. Metrics' facilities are regularly inspected and meet DEA guide-
lines for Schedule II-V controlled substances.
To offer a better idea of Metrics’ CTM and commercial batch capacities, it can process batch sizes up to 450 kg. Basham says that Metrics’
capacities are ideal for smaller patient populations and companies
that have “niche” quantity needs – as compared to larger CMOs.
EXPERTISE AND SPECIALTIES
While Metrics is quite adept at formulation development and
AMI Line TOC -
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Quick results appearing in less
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Quick and easy grab sample
Automatic system suitability
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Automatic function test - daily,
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manufacturing CTM for many dosage forms,
Basham notes that their specialties lie in the
areas of scale-up and bioavailability enhance-
ment. “We have particular expertise in handling
compounds that have poor bioavailability,” says
Basham. “We’ve done well with those materials.”
The company has developed intellectual prop-
erty in the oral drug delivery area – a matrix
system that mimics the action of an osmotic
pump. Tablets with an osmotic pump feature a
very fine hole that absorbs water and pushes
API out of the hole. Metrics uses a matrix com-
bination of excipients and API together with a
functional coating to achieve the same concept.
Metrics now offers two other technologies to make oral solid
dosage forms perform better – both of which have come from its
alliance with Mayne. SUBA™ is a novel drug delivery technology
for enhancing the bioavailability of poorly water-soluble drugs, and
Cleantaste™ is a proprietary technology to mask the taste of API in
liquids and tablets. This technology enables polymer coating of individual drug crystals to produce fine, non-gritty particles sized 25
µm to 125 µm (see sidebar for more detail).
FAST TRACK FORMULATION DEVELOPMENT
Sometimes a client comes to Metrics needing formulation help in
a hurry. Metrics has developed a fast track program that can deliver
Phase I clinical lots to a client in approximately 12 - 16 weeks.
"If someone brings us a NCE (New Chemical Entity) and it hasn't
been in a 'first in man' clinical trial yet, we can provide them with
solutions," says Basham. “We characterize it and can do a conventional capsule formula – or a neat API - pure API not mixed with excipients - in a capsule or bottle."
“Of course, all analytical methods have to be in place and validated,” he adds. “We will do 30 days of stability testing, the manufacturing, put it all in a package, put it in their application and off
LOOKING TO THE FUTURE
As Metrics looks to the future, its goal is to continue to build on its
current strengths and further benefit from its relationship with Mayne.
Metrics plans to expand its potent and cytotoxic capabilities.
“We have land available and part of the site development plan with
Mayne is to expand our capability in that area,” says Basham.
Additionally, the relationship with Mayne has given Metrics the
financial foundation to expand other areas of their business. For
example, the company is adding a segregated development facility
with equipment separate from its GMP area. The area includes five
manufacturing suites and a large analytical lab. "Our clients have
been pushing us to move through the early phases of development
and proof-of-concept without having to keep GMP standards," says
Basham. “You can do those things quickly without the cleaning verification requirement."
“It’s an exciting time for us and our clients,” concludes Basham. ■
METHOD DEVELOPMENT AND/
OR VALIDATION SERVICES
• Chromatography (LC and GC)
• Dissolution (UV and LC finish)
• Moisture (Karl Fischer)
• Particle Size (Malvern)
• Ion Chromatography (Dionex)
• Particulate Matter
• Cleaning Methods (LC and TOC)