As if Brexit, the scaled-up production of vaccines and spiralling demand for cold chain storage wasn’t enough, Dr Kevin Robinson spoke to Recipharm’s Lukas Spanier and Sharp Services’ Alexander Schäfer to get an insider’s view on the biggest pharmaceutical packaging trends of 2021
It’s almost a cliché now, but the search for capacities to support COVID-19 vaccines and treatments has been the dominant trend throughout 2021, notes Alexander.
The demand meant that the packaging industry had to shift capacities or create new solutions, putting a major focus on vial packaging at higher volumes and speed. Vial manufacturers have most probably faced the highest demand they’ve ever seen.
There were also a few knock-on effects, including material supply limitations that disrupted many supply chains. Promisingly though, the pandemic has sparked increased interest in more patient-friendly and convenient injection devices.
The key trend that we’ve seen beyond the COVID-19 bubble is the growing momentum in gene therapies. The industry has started to look for specific packaging and logistics capabilities to support their products.
The circular demand chains completely disrupt traditional logistics and require new thinking — all the while backed by specialist capabilities in frozen storage, cold chain packaging, on-demand packaging and distribution.
The most significant trend we’ve seen this year is the industry moving from serialisation to full aggregation for optimum track and trace of pharmaceutical products to protect the public against counterfeit medication, adds Lukas.
Many contract development and manufacturing organisations (CDMOs) don’t yet have the technology in place to offer full aggregation efficiently. Recipharm, however, invested in aggregation technology very early on, when the industry was beginning to explore serialisation. As such, we are well placed to support the industry in terms of achieving comprehensive traceability.
Kitting within secondary packaging is also a major trend, particularly in the biopharmaceutical space and in the arena of small-batch niche therapies. These pose particular challenges when it comes to maintaining packaging efficiency and often require manual processes. CDMOs such as Recipharm are constantly exploring technologies and approaches to streamline the kitting process to optimise efficiency.
Finally, sustainability is another key trend. As the global economy in general takes steps to reduce its environmental footprint, an increasing number of pharma companies are exploring potential solutions to enhance the sustainability of drug packaging, at the same time ensuring that the product within remains stable and safe to use during its advertised shelf-life.
Recipharm is collaborating with packaging material suppliers to identify solutions that achieve both stability and sustainability goals in the future.
As well as working with component suppliers to develop sustainable packaging solutions for clients, we’re seeing a demand across the supply chain for greater collaboration on environmental issues, says Alexander.
Earlier this year, Sharp and seven other supply chain partners cofounded the Alliance to Zero, a new supply chain association that is wholly focused on enabling the launch of “net zero” pharma products.
Sustainability is not just a trend, it’s more of a paradigm shift for every industry and we expect it to be central to the pharma packaging conversation going forward.
KSR: How is the uncertainty around Brexit impacting pharmaceutical packaging?
LS: The UK’s decision to leave the EU has resulted in significant implications for pharmaceutical companies manufacturing and trading on both sides of the Channel.
The regulations, export procedures and pharmaceutical packaging governing cross-border trade have been changed dramatically, especially when it comes to batch releases. Currently, the location of the batch release must be stated in the package leaflets of imported products.
However, CDMOs and packaging partners are responding to these changing requirements and are working to support customers who need to transport their products across the UK/EU border as smoothly as possible.
Recipharm, for example, offers flexible capacity on both sides of the Channel to help customers adapt to the new regime. It also has in-depth knowledge of the regulations and trading rules in the EU, UK and the rest of the world, so is well placed to ensure that customers can continue to manufacture and sell their products internationally and in both jurisdictions.
AS: This is not a packaging-specific problem … but a general problem for all UK/EU cross-border supply chains. Every company is trying to mitigate the risks related to Brexit and navigating the new rules and regulations. Every industry is in the same boat, so to speak, and it will take time and resources to overcome these disruptions.
The result is that there is a reluctance to work with UK-based partners when the majority of demand is for EU markets. However, there might be some upsides for domestic UK product and items going straight into overseas markets outside of the EU, depending on the trade arrangements that come into being in the coming years.
KSR: COVID is driving demand for vaccine fill-finish, secondary packaging and specialist handling and shipping requirements. How is the industry meeting these demands?
AS: We’ve seen substantial investment in new fill-finish and vial packaging capabilities in the last 2 years to support worldwide demand. This surge both prompted CMOs and CPOs to expand their capabilities and also opened doors for new collaborations and partnerships.
Certain existing capacities have also shifted towards supporting COVID-19 vaccines, which has potentially created a risk that other products might be deprioritised at companies with fewer resources.
LS: There is an increased reliance on digital printing for commercial use to avoid long print runs, high minimum order quantities (MOQs) and inventory levels for vaccines.
Larger CDMOs with facilities in multiple countries and with agility already built into their packaging infrastructure are well placed to support pharma companies to meet surging international vaccine demand. They are also able to offer cutting-edge solutions, such as digital printing, to meet increased demand quickly and efficiently.
KSR: What do you see as the biggest hurdles in the coming years for the pharmaceutical packaging industry?
LS: Packaging tailored drug products — that are personalised for patients and customised for the regulatory, cultural and language needs of individual markets — is a key challenge that needs to be overcome.
Agility is needed to package these smaller-volume products effectively, which adds complexity and cost. Pharma companies often don’t have the in-house capacity or capability to achieve this, nor do they have the ability to perform changeovers efficiently or flexibly.
It’s important to work with CDMOs and other contract partners to meet future packaging needs.
These companies have the expertise and dedicated infrastructure to package products accurately and efficiently, and the ability to change over to different SKUs as quickly as possible with minimal downtime. With this support, packaging companies can ensure they are able to meet the growing tailoring trend while maximising productivity.
Finally, as mentioned earlier, sustainable packaging is another challenge for the future. It is crucial to find new solutions that are truly sustainable and, at the same time, deliver the same level of product stability to maximise shelf-life. Recipharm is exploring potential packaging options to achieve both goals to support our customers’ future environmental goals.
AS: The biggest issues we’ll need to manage will be what to do with all the “extra” capacities that were created to support COVID-19 medicines. Will they be required in the future years? If not, how do companies plan to make returns on their investment, and how will they go about repurposing and utilising the spaces previously dedicated to vaccine production?