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Pharmaceutical Manufacturing and Packing Sourcer
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The continuing growth of – and increasing move to – large molecule
medicines naturally calls for greater reassurance of
temperature-controlled packaging reliability. Across the life sciences
and packaging industries, there are benefits to be had from an
all-encompassing, standardised measure of performance for the
temperature-controlled systems used to transport often high-value
assets.
There needs to be a more universal approach. Currently,
many vendors demonstrate the performance of temperature-controlled
packaging by showing an example of performance – most often carried out
with an ambient test profile that shows how the packaging will respond
to a particular simulated shipment route. However, this method has its
drawbacks.
The 'go-to' industry standard for performance
regularity is mainly via the International Safe Transit Association
(ISTA), which represents a collaboration of manufacturers, packaging
suppliers, testing laboratories and carriers working together to try and
ensure responsible packaging. Previously, organisations like ISTA have
tried to create a standard profile to capture, in essence, the worstcase
scenario of what could happen in any given transport situation. But
what that ends up doing is further widening the possibilities of
creating packaging that is not always fit for purpose. The customer
might end up with packaging that is over-designed for what it is needed
for.
ISTA’s initial focus was on the mechanical testing
sequences, used to prove the robustness of overpackaging for everyday
products such as ovens and washing machines. More recently, the
association has established thermal test procedures for insulated
packaging: one of the profiles widely adopted in standard qualification
is ISTA 7D, while the more recent ISTA 7E is viewed as an industry
standard.
With the emergence of the new generation of
biopharmaceutical medicinal products – coupled with new, remote and
logistically demanding markets – the issue of being able to deploy
reliable, high-performing shipping systems is paramount. The rapid rise
in biopharmaceuticals, generating global revenues of $163 billion,
equates to somewhere in the region of 20% of the pharma market – making
it by far the fastest growing part of the industry.
Standardised System
Pharmaceutical
products are increasingly having to be transported via challenging
shipping routes – facing the risk of being exposed to greater
temperature stresses or unplanned hold periods like customs clearance.
As a result, the introduction of a new industry-wide standard
performance measurement is something that should be at the forefront for
decision-makers.
There needs to be a collaborative call for a
standardised measurement system that is easy to implement and can be
adopted worldwide within the sector. The new generation growth of
biopharmaceutical products that are highly temperaturesensitive and must
be stored and transported within a specified temperature range give an
even greater urgency to this situation. Why not implement a thermal
stress score, a standardised procedure, calculated by stress testing
with universal acceptance?
Kelvin Hours
For greater
reliability, a standardised method such as Kelvin Hours (KH) could be
implemented and recognised as a new industry standard for the global
temperature-controlled packaging industry. It places the emphasis on the
shipping system’s performance capabilities.
The benefits of
adopting KH as a standard performance measure is that it does not tie
itself to a particular ambient test profile. Rather, it is centred on
what the specific selected shipping system is capable of doing;
therefore, you can say that a particular shipping system will perform
against ambient profile X, Y or Z for a specific number of hours for
those different demands. It makes for a less subjective and more
measured approach. KH could be collated via a simple equation: average
thermal stress (K) x control duration (hrs) = Khrs. Adopting this
calculated stress testing, using vendor qualification data, would enable
simple, fit for purpose evaluations.
KH could easily be adopted
as a tool to select the most appropriate level of performance of
packaging. This could be used across the board, with a broad range of
performance points for the newer-style phase change material (PCM)
systems, which is where the KH measure works particularly well.
A
company using temperature-controlled packaging can assess shipping lane
data using KH, and select a packaging system that satisfies the minimum
performance requirement. Essentially, this matches the shipping system
to the challenges it is going to face, as opposed to having one shipper
option and then finding only half of its potential performance has been
used in a particular shipping lane.
Patient and Industry Reliance
The
need for a new, standardised measure of performance was not so pressing
before, with the shipping of small molecule products that are
potentially less temperature-sensitive. However, the new generation of
large molecule products – being developed for relatively rare conditions
such as various cancer treatments – rely on high-performance packaging
systems to prevent their complex, fragile structures being destroyed.
These
sophisticated medicines are a lifeline for huge numbers of patients,
helping them overcome or manage certain diseases, so it is vital they
arrive intact and perform properly. At the same time, pharma companies
developing products to treat such conditions rely on shipper performance
when supplying for clinical trials. It is at this early, risk-heavy
stage, when there is no stability data for the medicines being trialled
and it must not go outside a temperature window, that a robust shipping
system is required. The safe transportation of both the medicines being
trialled and the supply of comparator drugs is crucial.
Comparator Supply
New
products being developed have to be tested against similar drugs on the
market, usually manufactured and sold by a competitor. Pharma companies
have to buy these products at market value, which is often very
expensive. Coupled with the fact these companies do not have access to
any stability data, they have to ship the payload within a strict
temperature range to know it is going to be as effective as it should
be. Indeed, the cost implications related to this comparator drug
testing can be extremely high, and can constitute up to half of the
total budget allocation of a clinical trial.
If the comparator
drug goes to waste because the packaging selected for the transportation
is substandard, due to a lack of a well-defined performance measure,
the costs can be unbelievably high. For example, a 10ml vial could cost
tens of thousands of euros for a single dose.
Product Scoring
An
industry-wide standardised performance measure such as KH is being
driven by the development of large molecule products, as well as the
growth of gene therapies and manipulating proteins in research into
certain conditions like cystic fibrosis. The reassurance in packaging
provided would be particularly relevant in the clinical trial sector,
where Big Pharma is focusing more R&D in high-value niche
application products.
If a new KH approach was adopted across the
industry, there would be different levels/points of performance, or KH
scores. This, in turn, would make it easier to match the score with the
appropriate shipping system required.
Technically speaking, a KH
scoring system could be used to appraise performance at the actual stage
of preparing the packaging. This could revolutionise the packaging
industry. Rather than selecting a shipper for a particular duration, it
would be a case of choosing the appropriate shipper with the relevant KH
score attached to it. For further ease of use, a customer could
describe the challenges of their specific shipping lane and receive a
score that would help them pick the best packaging product for their
their needs. This would also have signifi cant cost benefits as it would
help to avoid using a product that is over-engineered for its purpose.
Speed and Simplicity
This
proposed approach would make it much easier to compare one set of
products against another. At the moment, because there are so many
different ambient test profi les being used in the industry, performance
– or the appreciation or perception of performance – can be skewed. KH
scoring would work especially well with newer PCM systems; the area in
which it probably needs a little more development is in older
water-based technology.
Most of the new product development being
seen in the temperaturecontrolled packaging industry incorporates
newer, more advanced materials, but there is still a signifi cant
proportion of the market using these older water systems, purely due to
the cost restraints.
Packaging suppliers often have ambient profi
les against which they qualify their packaging. Also, some customers
have their own profi les which they request suppliers to qualify against
– they see these as indicative of what they would expect during
distribution of their product. Each customer will have a different view
on what that looks like.
Given that the whole qualification
process can be extremely time-consuming, a new industry-wide performance
measurement would introduce speed and simplicity – benefiting not just
packaging suppliers but also those who have to specify the packaging.
When aware of the temperature challenges expected in a shipping lane, it
can be used to create a KH score: in theory, whichever suppliers have
packaging tested to the standardised score should have the shipper most
appropriate for the job.
Passing the Test
Over the
last five years, there has been a notable rise in the temperature
monitoring of pharmaceutical products. Depending on which region a
product is being shipped to – for example, emerging markets such as the
Middle East – customs control may open a temperature-sensitive package
with a data logger inside it, in order to inspect the data logger and
check it is still within temperature. If it has not been maintained at
the correct temperature up to that point, the package could be sent
back.
The industry needs to change in order for the ever-more
sophisticated medicines being produced to be effective and to reach
their destinations. If they get too hot or cold, and if they are
protein-based, the proteins can denature and lose efficacy –
jeopardising what could be life-saving treatments for patients. It
remains to be seen whether changing to a standardised method, such as
KH, can truly allow companies to significantly enhance their
performance.
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Extractables and Leachables Testing: A Risk Based Approach
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Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
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The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023)
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The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023) gathers top-level management from pharmaceutical
companies of manufacturing, primary and secondary packaging, purchasing,
and supply chain and procurement sectors, CMOs and CDMOs leaders, heads
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