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International Clinical Trials
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In the advent of ever-more stringent regulatory requirements, and the
need for more sophisticated shipper solutions for the safer transit of
pharmaceuticals and biologics, temperature-controlled packaging
manufacturers are required to be increasingly vigilant when it comes to
mitigating cold chain risks.
When it comes to the transportation
of clinical trial materials and pharmaceutical products – particularly
in light of the significant rise of biologics and biosimilars within the
industry – a minor temperature excursion during their journey can have
costly consequences for patients and pharmaceutical companies. This is
especially pertinent within the trials sector, where patient safety and
efficacy are of paramount priority.
New Challenges
More
than 50% of new drugs are going to be biologics or biosimilars in the
clinical trials marketplace, which is a key driver in the increasing
demand for tighter temperature control requirements. Within clinical
pharmaceutical studies, there is an ever-greater need to protect more of
the drugs with more stringent temperature-controlled ranges, due to
them being based on biological, rather than chemical, compounds. This
provides the industry with further challenges, including the following:
Growing Market
The
clinical trials marketplace is a growing area within the
temperature-controlled packaging industry, and currently accounts for
approximately 20-25% of the overall market share. The larger volumes
commercially are concentrated on when these drugs go to market and are
being distributed globally.
While around a quarter of the market
may be dedicated to clinical trials, it is a significantly more
challenging sector to operate in, due to the temperature ranges required
to ensure the safe transportation of these high-cost, high-value and
often life-saving medical materials to emerging markets, which pose
their own extreme temperature range risks.
Emerging Markets
The
biggest hurdles facing the temperature-controlled packaging industry
are more complex distribution lanes, far-flung global locations and
increasing regulatory requirements. While the industry infrastructure
within the regions of Europe, the US and latterly parts of Asia are
acknowledged as being proficient when it comes to legislative
compliance, emerging markets posing greater challenges include Brazil,
China, India and Russia.
End of the Line
Last-mile
pharmaceutical transportation is another growth sector requiring that
stringent regulatory demands are adhered to, with an increase in
ensuring the protection of high-value, temperature-sensitive pharma
payload end-toend. These bespoke deliveries mean there is a heightened
industry requirement for smaller sample shipments needing assured
temperature-controlled protection throughout the entire supply chain.
Globalisation
In
the current clinical marketplace, it is essential to know what is
happening worldwide and to fully understand international processes and
trans-requirements. With greater globalisation, it is vital to employ
competent staff in these more remote locations that understand all the
region-specific regulations, know what the trends are and explain what
is happening in emerging markets. A global presence, and being in situ
to understand regulations and transportation needs in different regions
of the world, is also critical. Manufacturers can achieve this with
representatives from their own business or, in some cases, companies
will enter into partnerships to give them more global coverage or
support.
Regulation
From Europe to America and Asia,
there are now more and more agencies and organisations producing
specific incountry guidelines and regulations that drug companies are
required to support and be prepared for. These would be industry issues
that quality assurance (QA) representatives within pharma organisations
will be aware of, study and learn, then drive within their business.
These regulations are driving demands that manufacturers are then
supporting with pioneering temperature-controlled packaging systems, and
the packaging industry works closely with the QA organisations within
the pharma sector to meet the evolving challenges collaboratively.
From
a manufacturing standpoint, the industry is virtually governed by
medical device similar standards or Good Manufacturing Practice (GMP)
guidelines. From a temperature-controlled packaging manufacturer’s
viewpoint, there needs to be strict and thorough quality procedures in
place, such as International Organisation for Standardisation or more
akin to GMP quality standards, when operating in more remote regions.
Industry Innovation
The
temperature-controlled packaging industry is moving towards the
implementation of new and innovative technologies to successfully serve
the clinical trials transportation sector and wider pharma arena. What
is becoming more prevalent in particular is the rise of phase change
materials (PCM) and vacuum panels for insulation. These innovative tools
are the main drivers in mitigating cold chain risks of pharmaceutical
payload transportation.
For clinical trial clients, key
considerations are performance, ease of use and assurances that
temperature-controlled vendors are engineering the most efficient and
reliable shipping solutions to mitigate cold chain risks.
When
it comes to the systems being utilised for clinical trial drug
distribution and biological sample transportation, performance is being
driven by the emergence of newer technologies. This is in conjunction
with a focus on making functions and processes more simple and
cost-effective from the outset, based on developing simple preparation
and pack-out procedures.
Cost-Effective Solutions
As
well as mitigating cold chain risks when shipping clinical trial
materials, the ever-evolving nature of this specific sector means the
temperature-controlled packaging industry must continue to strive to be
one step ahead when it comes to producing pioneering packaging products
to meet the demands of clients. Increasingly, the clinical trials
biologics market is trying to learn from their commercial colleagues and
deliver the prerequisite performance – and do it costeffectively, so it
comes down to evaluating and addressing the overall total cost of
ownership; not just the price of the physical packaging, but also of
managing the cost of its transportation and distribution. Outer and
inner dimensions, and the volumetric efficiency that newer technologies
can provide, are important criteria for clinical trial clients for
continuous consideration.
Ultimately, customers expect a great
performance, ease of use and a reduction of their shipping costs,
because they have utilised a box that is half the volumetric size, but
the same or greater payload. However, what is becoming increasingly
evident is that clinical trial managers are learning from colleagues in
the commercial side of pharmaceutical distribution, and cost
effectiveness is a key factor alongside the total cost of ownership.
Key Considerations
By
reducing the number of components in a pack-out, the process of placing
the payload and coolants within the thermal packaging would make
compiling the package more straightforward. Having a single – rather
than multiple – conditioning requirement also has an impact across the
industry to combat cold chain excursions.
There is a further
significant advantage to being able to have conditioning or packaging
protocols in place for year-round use, instead of modifying from season
to season. Some of these emerging technologies allow companies to
accomplish this via easier conditioning or preparation methods, coupled
with easy pack-out that is the same year round, not winter versus
summer.
Creating a simplistic solution is equally as important
as performance, because one of the biggest risks in the cold chain are
temperature excursions – and the vast majority of those occur due to
package pack-out errors, namely human errors, during the packaging
process. Therefore, ease of use, performance and administering all these
elements as cost-effectively as possible are the current drivers in the
transportation of clinical trials products to further guarantee the
integrity of temperature-sensitive medical materials along the cold
chain.
Marked Shift
In a bid to simplify
packaging procedures, and to ensure greater performance reliability
within the packaging industry, there has been a marked move away from
the older coolant methods, which utilise water. Previously, older
technologies – such as water-based ones – would often require seasonal
pack-outs covering all four seasons, thereby relying on seasonal
instructions, which in turn drives the need for further training and
additional warehouse personnel.
Cost savings can be made and
passed on through the supply chain process by minimising the methods
required and subsequent training. To achieve this performance and to
mitigate the risk of the pharmaceutical payload being affected, damaged
or perished by any excursions en route, manufacturers need to be able to
repeatedly construct the packaging in the same way, every time.
The
simplicity or ease of use becomes ever-more critical to driving that
performance, which, in turn, pushes towards the efficacy of the drugs
and patient safety: the ultimate goal.
Advanced Technologies
Some
of the most recent developments within the industry include the
emergence of pioneering tools that allow temperature-controlled
packaging companies to manage this new technology better. In essence,
they are technical tools that assist with performance modeling, and
software tools that allow businesses to develop performance modelling
more easily.
These testing techniques include software that
enables companies to create a temperature profile easily and which they
might want to test against a specific lane. Another new innovation is
the introduction of indicators on PCM panels that allow the user to know
when they are ready for pack-out, which can simplify standardised
procedures.
These indicators on PCM panels and innovative
software are some of the latest developments made by
temperaturecontrolled packaging manufacturers. Technology supporting the
best implementation of these new innovative tools, including software
modeling, testing, managing the preparation process and indicators –
which allow for understanding the temperature of the panels – are some
of the major innovations happening at the moment to help clinical trial
customers.
Currently, the industry is moving towards these newer
technologies, looking at tools to assist in the management of more
modern PCMs, which are more technologically advanced than water-based
systems.
Reusable on the Rise
While single-use
packaging still has its place and serves a purpose – particularly when
it comes to more difficult to control or challenging lanes when the
retrievable infrastructure is in place – reusable packaging, which is on
the rise, can prove a more cost-effective option. Reusable technology
is becoming more and more accepted, because it can really drive down
costs per use. The packaging industry is working hard to try and change
preconceived perceptions about reuse and its reliability.
Clinical
customers can obtain access to advanced technology and make it much
more affordable, thereby reducing the total cost of ownership by
recapturing and reusing that packaging asset over and over again.
Future-Proofing
To
best serve the clinical trial industry’s rigid requirements, packaging
manufacturers must continue to strive to set and surpass standards,
creating shipping solutions best placed to meet the evolving, exacting
pharmaceutical protocols. The impetus is increasingly in industry
innovation, and future developments will involve standards that
demonstrate ways to guarantee multiple reuse packages are fully
qualified, remaining fit for purpose after multiple uses.
The
question currently facing the packaging industry is: how to test and
qualify reusable packaging in order to know, one or two years from now,
or 10, 20 or 30 uses from now, that it is still delivering the
performance it was initially qualified for? As well as a shift towards
reusable technology, the packaging sector is trying to ensure customers
can leverage new technology, use it effectively and know that it is
truly qualified years down the road.
Convincing clinical trial
firms of the importance of having the right cold chain system as part of
their overall operations and budget considerations is an ongoing
challenge, alongside helping customers grasp the financial impact of
temperature-controlled packaging and how vital it is within their
organisation and its operations.
It comes down to helping
clinical companies better understand the true cost of moving to newer
technologies, and what impact that can have for their operations.
Manufacturers ensure this is all transparent so the client can see,
document, measure and understand it. The flipside is considering the
impact of not managing their cold chain operations effectively.
What
are the implications of clinical cold chain excursions and, crucially,
what is the potential human cost of having inefficient transportation
systems, which can render drugs ineffective and, ultimately, put
patients' lives at risk?
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