An interview with Almac's David Downey, Vice-President Commercial Operations
Pharmaceutical Processing spoke with David Downey, Almac's Vice-President of Commercial Operations to
get his views on packaging trends in
general and some of the issues facing
with a single supplier
to ensure on
Is there a trend toward more sterile or
cleaner packaging environments?
Sterile environments tend to be exclusively
the purview of filling operations. Thankfully
packaging operations are managed within
a “pharmaceutically clean” environment as
required by GMP. However, Almac Pharma
Services operate our packaging operations
within a Class 100,000/Grade D background.
This exceeds the requirements of GMP
but it's a standard approach within Almac
Pharma Services to control the environment within which a product is packed.
wallets, with the use of complex, yet user
friendly artwork to address patient compliance.
The ability of our pack design and artwork teams to address client needs and
provide mock-ups for marketing assessment or submission purposes means that
expertise and solution provision in this
area is important.
Similarly with our continued focus on
orphan and niche drug launches, kitting
of complex biopharmaceutical packs is
becoming the norm. This can often involve
the design and label/assembly of a patient
pack involving the drug, companion diagnostic, plus ancillary items.
Lastly, as we have a dedicated penicillin
packaging facility in the UK we package
multiple combination products for the EU,
US and ROW markets.
is a “no
David Downey, VP Commercial Operations, Almac
Are there any new dosage forms that
you see as becoming more popular? If so, what are they and
do they pose any packaging issues?
Yes – lifecycle management, innovation and compliance are
driving numerous “new” types of dosage forms. For example,
combination products such as fixed dose combinations, bi-and tri-layer tablets and multi-product blister presentations
offer pharmaceutical companies an option to treat multiple
conditions within a single presentation.
Similarly, we have also seen an increasing interest from
our clients in pediatric presentations as a result of recent
regulatory changes. Addressing the challenges of encouraging children to take their medicine has opened up additional
drug formulations such as powder in bottle (for reconstitution) and flavored powders in sachets.
On the packaging front we see more clients requiring
product packaged in temperature and humidity controlled
environments. All these challenges present opportunities to
Almac Pharma Services as we pride ourselves on our ability
to provide solutions to our clients through dedicated engineering, quality and project teams.
Are sponsors asking packagers to provide
other services such as molding, forming,
graphic design, etc?
Yes – our clients are pleased to find that we can provide the
value added services such as tooling and pack design, artwork
management, QP services etc. Simply it means that clients can
leverage these additional services from Almac without having to
outsource further – it makes life easier for our clients. Integrating
project plan elements with a single supplier to ensure on time
launch, mitigate risk, and reduce costs is a “no brainer”.
Have you seen an increase in requests from companies for different sizes, form factors or combo packs, etc.?
Again yes – packaging formats do seem to be trending away from
the simple tablets or capsules into bottles. We now package
multiple titration packs, combination products into blisters and
Are contract packagers being asked to help provide solutions
for drug counterfeiting issues, and supply chain issues?
Yes, with the increasing problem of counterfeit, misbranded,
adulterated and diverted drugs entering the supply chain,
clients are requesting anti-counterfeiting measures to be introduced more and more. Requests range from overt holograms/
watermarks to covert UV and IR reflecting inks to track and
trace solutions of 2D barcodes and full serialization.
Addressing the track and trace requirement, Almac Pharma
Services has developed an internal print and online verification system that applies and verifies 2D matrix barcodes to
each carton. Our Overprint Serialisation and Inspection System incorporates the Hapa Red Cube Printer, Cognex Vision
System (confirms data is correct) and LVS Verifier (confirms
quality) and ensures serialisation to GS1 Standards.
How important to a potential client is it for you to demon-