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 contract packagers.
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.
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.
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 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.
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”.
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 demonstrate flexibility in packaging operations?
Telling a client that they can have a packaging slot for a launch product next month just does not happen in Almac Pharma Services. Flexibility is key, particularly when a new product launch is involved. In our UK operations we have acted as site of launch for the EU market for more than ten orphan drug products in the last three years. A fully integrated and experienced project team consisting of Almac and client personnel follow a well worn launch approach that Almac have refined over many years. Objectives are defined within this plan with built in flexibility to address the challenges that sometimes arise.
How important is the input and expertise of packaging equipment vendors to the success of your operation?
Developing a close relationship with your packaging equipment supplier is always advantageous to ensure you are fully aware of the capabilities/limitations of the technology. Should technical issues with the packaging equipment arise a solid partnership with your supplier will also help minimize downtime through expedited response times.
Have you seen an increase in FDA inspections/audits? Do your customers inspect your facility now more than in the past?
Our new US commercial packaging operation in PA was recently inspected by the FDA with no 483s. However allowing for this milestone, our clients still have an internal audit requirement to visit and “sign off” the site. With 40 years of commercial manufacture and packaging experience in the EU we are well versed in client audits. As we grow the business, specifically within Almac Pharma Services, we are often seeing two client audits per week across our various service lines. Similarly, as we are named in more NDA’s, ANDA’s and MAA’s we see more oversight from the regulatory agencies, whether they be FDA, MHRA, ANVISA, JP authorities etc. We welcome these visits as it illustrates our ongoing growth and success.
Where do you see the biggest growth in contract packaging in the next five years or so? Will there be more growth in Rx or OTC products?
That’s a good question and one we thought long and hard about before opening our US commercial packaging operation. Personally, I believe big pharma will continue to outsource more contract packaging in an effort to reduce internal labor and overhead costs – this will particularly be true in the OTC space.
Additionally, I believe, and hope, that pharma focuses more heavily on quality and flexibility within that contracted packaging environment so we avoid the negative headlines of recalls, mislabeling etc.
For innovative Rx products Almac Pharma Services has seen more and more smaller companies do business with us on packaging/3PL of niche and orphan drug products, where all requirements are fully outsourced. This fits perfectly with the “one stop shop” model operated by Almac Pharma Services for this particular type of product.