Incorporating Comprehensive Serialization Solutions

in the U.S. Pharmaceutical Market

By Andrew Pietrangelo, President, North America, Antares Vision

In any discussion of the complexities of serialization, it’s important to focus on the finish line
as much as the bottom line. Past all the anxiety-inspiring talk of deadlines and guidelines,
and of mandates and must-haves, it’s worth remembering the ultimate goal of incorporating
a comprehensive track & trace solution into a pharmaceutical production line: the safety and
security of people, the end users at the supply chain’s final touchpoint.

Amidst all the scrambling and scurrying to meet pending regulations, it’s easy to forget
that, in terms of serialization, our overall goal as an industry is admirable and forward-
thinking: along with building a safer supply chain, we’re also creating a smarter, more
precise and potentially more profitable one. So as U.S. companies race to meet looming
regulatory obligations related to the Drug Supply Chain Security Act (DSCSA), it is critical
that all parties who are committing substantial capital and resources to serialization and
track & trace measures keep this is mind: The greater goal is the greater good.

Ultimately, implementing a serialization solution is similar to any new business venture. If

you build a people-pleasing solution, profits will come.

Implementation Barriers

There are a variety of barriers when it comes to the implementation of track & trace
technologies, including cost, complexity, and lack of coherent or cohesive regulatory
guidelines. Companies also need to manage OEM capacity, line packaging, line availability
for implementation, and data system integration.

But perhaps the biggest barriers are organizational in nature. Despite the proliferation of
what I call pharma’s track & trace culture, there remains a scarcity of people truly well-
versed in the language and skills needed to help companies evolve their operating models to
comprise more effective exchanges, both across their own organization and with partners.
This will undoubtedly improve over time … but time is of the essence.

Desirable Solutions for the Short Term & Long Haul

Not surprisingly, market growth for serialization services has skyrocketed as government
mandates in the U.S. and Europe draw nearer. The broader landscape, of course, is a
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legislative labyrinth: While U.S. and E.U. deadlines are rapidly approaching, many emerging
markets have serialization requirements that are either already in effect or currently being
enacted.

This being the case, as companies seek partners to help them meet short-term serialization
mandates on an expedited basis, they are also considering the long game. They know that
what’s compliant today won’t necessarily be compliant tomorrow, meaning track & trace
solutions need to be not only fast in coming but flexible for ongoing upgrades. Solutions
can only claim to be “best-in-class” if they are “future proof.”

A major, albeit obvious, takeaway from all this, placed in laymen’s terms: This stuff is really
complicated, it’s really crucial, and it’s really happening.

Promising Technologies

Necessity being the mother of invention, the good news is that innovation in the
serialization sector is booming. New anti-counterfeiting and anti-diversion technologies are
continually being developed to thwart illegal activity, including sophisticated layered
technologies that combine overt and covert printed features. Furthermore, in addition to
traditional UV inks, several companies have developed proprietary new inks that can be
easily added to some serialization systems. This allows pharmaceutical companies to move
beyond compliance to investments capable of bringing added value and ROI.

And increasingly, serialization implementation is being seen as a springboard for further

pharma factory digitization. Utilizing the troves of data generated by the track & trace
process, next-generation systems are translating raw line-level data into actionable
intelligence that leads to decisions directly impacting OEE, personnel allocations and other
business practices.

Vendor Selection

Given the aforementioned criteria, proper preparation and careful vendor selection is critical
for pharmaceutical companies that want to remain current, compliant, and competitive.

In addition to considering the impact serialization has on their packaging lines, pharma
companies must also consider other, often-overlooked details such as package design,
standard operating procedures (SOPs), warehouse workflow and re-aggregation. Choosing
an experienced solution provider can help assure that implementation timeframe, cost and
risk all will be reduced.

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Understandably, pharmaceutical manufacturers are seeking out companies with global track
& trace experience: Leaders who have developed and helped deploy established solutions
that balance stringent regulations with ease of operation. They crave solutions that can
work with existing equipment, but are flexible enough to meet future needs – many of
which have yet to be determined. Fast delivery times, competitive pricing, and excellent
customer and technical service also are must-haves.

My company, Antares Vision, has long anticipated the heightened demand for top-notch
serialization solutions, and has continually invested in the engineering prowess, capital
equipment and technology needed to become a leader in serialization implementation.
Antares Vision has installed solutions on well over 1,000 production lines in more than 200
plants around the world, with more than five billion stock keeping units (SKUs) serialized,
aggregated, shipped and notified utilizing these solutions.

A brief example: A well-known Philadelphia-based contract packager selected our company

after evaluating several competing serialization equipment providers and integrators for
their global platform. Modularity and flexibility were key factors in the vendor selection
process. The contract packager targeted its largest operation center, in Illinois, as its first
installation location, and has successfully integrated our technologies into its high-speed
automated and multi-step packaging lines. It also has utilized our equipment as an a la
carte solution for varying size and packaging configurations. This successful implementation
provided a robust platform for additional installations both at the company’s North American
headquarters and at several sites in Europe.

Benefits for All

The truth about the mad rush to serialization is that, when all is said and done, the greater
good will have been achieved. Government, industry, and vendors are all driving track &
trace advances forward and, as pharmaceutical companies complete their implementation
processes, they are pressing vendors to deliver solutions that minimize impact on operational
efficiency and standard operating procedures. As a result, vendors, in order to stand out from
the crowd, are proactively developing unique solutions to satisfy a variety of industry needs.

Ultimately, this is a positive for all stakeholders – pharmaceutical manufacturers, industry

vendors, and the public. The investment is worth it: When pharma companies comply with
government regulations, they eventually recoup the costs associated with this compliance
by benefitting from reduced losses from counterfeiting, higher visibility in the supply chain

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and positive user feedback. In due time, today’s efforts will more than pay for themselves
through improved business efficiencies, consumer safety, and customer satisfaction.

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About the Author

Andrew Pietrangelo is President, North America for Antares Vision, which is recognized as
the world’s leading provider of serialization-based track and trace solutions for the
pharmaceutical industry, with more serialization systems installed worldwide than all major
competitors combined. Antares Vision has installed solutions on over 1,000 production lines
in more than 200 plants around the world. More than five billion stock keeping units (SKUs)
have been serialized, aggregated, shipped, and notified utilizing Antares Vision solutions.

Comprising both hardware and software, Antares Vision’s solutions stem from strong
relationships with best-in-class technology vendors, including enterprise application
suppliers; packaging OEMs; manufacturers of cameras, printers and labelers; and software
and communication providers. For more information, visit www.antaresvision.us.