In his book, The 7 Habits of Highly Effective People, the author Dr. Steven R. Covey emphasizes beginning with ‘the end mind.’ This means beginning each day, task, or project with a clear vision of your desired direction and destination, and then continuing to flex your proactive muscle to make things happen. In today’s pharmaceutical market, when it comes to secondary packaging, these words have equal significance.

Pharmaceutical and biotechnology companies with a drug product in clinical phase III are usually focused on manufacturing scale-up while secondary packaging often doesn’t get the serious attention it needs. Correlations with secondary packaging that are not considered in this phase can have a negative effect on further processability, the variability of the forms of presentation, or on cost and time-to-market. Therefore, starting early to discuss the secondary packaging strategy can save you time and money.

From our experience as a globally leading contract development and manufacturing organization (CDMO) we would like to demonstrate some of those correlations and give you some food for thought. And so, when does one begin creating a strategy for secondary packaging?

The impact of primary packaging
The best starting point is usually when discussing the primary packaging. Without question, the choice of primary packaging has a strong impact on downstream secondary packaging. Consider, for example, the combining of a syringe with an autoinjector or safety device. The format and dimensions of the syringe as well as the barrel flange need to fit to the respective system.

Additionally, the assembly machine needs to be able to process the combined format parts and it should be certain that the syringe is designed to resist higher mechanical forces. Whenever a drug is launched in an autoinjector, it is set up on an existing platform that usually needs customization and usability studies. Allowing for extra time for device customization will help to achieve a realistic timeline.

Specific indication and market requirements
Planning for the best possible solution requires a focus on the administration use case. User, use context and the route of administration can influence requirements of secondary packaging. Consider the handling of ophthalmic syringes utilized in a professional setting. Intra-ocular administration is an action that needs fine motor skills and differs significantly from syringes used for home use, e.g. for arthritis. Consider too, that age and educational levels also have an impact on drug administration.

Differing country/market specifics can demand extra time that needs to be considered. For example, you must allow extra time for the creation and internal approval of artwork required for multi-country/market labels and booklets. The reimbursement landscape can have an impact on your market approach and market acceptance of your secondary packaging solution. This can be true for doctors, medical professionals, payers and for patients.

For instance, one could imagine that health insurance companies prefer an autoinjector over a vial kit as the patient can administer it at home and, therefore, saves professional administration costs. Doctors, on the other hand, might prefer the professional administration because they want to monitor their patients, e.g. after injecting an oncology drug. In some countries like the U.S. and Germany, doctors may also prefer a vial kit over an autoinjector because there are more application steps involved and each of them is reimbursed.

Challenges from regulatory authorities
Additional market approval demands and extended documentation for more sophisticated solutions such as autoinjectors can influence a product’s time to market. We often encounter customers that plan to launch several variants such as a syringe and autoinjector at the same time. They often end up with a staggered market launch where the simpler variant is approved first and the more sophisticated one follows with delay.

Country specific regulatory requirements such as additional labels or mandatory variable data can place demands for extra space on the packaging itself. Given differing country and packaging variants, a big batch size in filling often melts down into much smaller country specific secondary packaging production orders. A dedicated launch and supply chain strategy will assure the most expeditious time-to-market.

Market differentiation
Secondary packaging gives you the chance to differentiate your product against competition. When done in the best way, differentiation in secondary packaging is focused on the use case and the user needs—such as those already mentioned in the specific indication requirements section. When solving user specific needs, like limited fine motor skills, with a packaging that is easy to open and a device that allows correct administration despite the motoric limits of the users, your product’s marketing opportunities rise. Enhanced functionality and higher convenience often support a product’s safety by ensuring a safer administration and avoiding user errors. Even adherence can be positively affected when administration is easier, less painful or simply done quicker.

Enhanced functionality and convenience might also be part of a dedicated product lifecycle strategy that evolves over time. Not delivering the full potential with the first market presentation might be worth considering, especially if time to market is crucial.

Volume scale-up
Demands and related production order sizes for secondary packaging expand significantly from clinical to commercial. Expect that your partner or in-house production unit is experienced and flexible enough to handle your needs from small-scale to large-scale production with stringent quality. A scalable production setup with a high grade of automation that can cover anticipated changes in a product’s demand helps to ensure quality and reliability. Also, it is very helpful to have a supply chain that is capable of reliably delivering the same quality at whatever quantity. Decent in-house engineering and tooling skills support you when existing equipment needs to be adjusted, and they provide extraordinary support in case of errors. A proven track record in qualifying and establishing solid processes rounds off the skill set that facilitates a dependable supply security.

Future trends
Several factors drive the smart monitoring demand for pharmaceuticals. Authority’s demands for commercial products are rising. The FDA emphasizes real-word evidence of efficacy. EMA’s post-market surveillance demands are rising to monitor a product’s safety. Payers and pharmacy benefit managers want to be sure that medication is beneficial, that patients are taking their medications as prescribed and that they work.

Depending on the region, pay for performance is becoming more popular, especially for expensive treatments. Collected data provide the chance for a deeper understanding of diseases and patient behavior, which is highly interesting for medical professionals, pharma companies and payers. Digital enabled technologies like smart labels and connected devices will evidently play a significant role in the future.

Since the issue of sustainability became a megatrend, it is gaining traction within the pharmaceutical industry. Big pharma companies discovered this topic as a good fit within their CSR (Corporate Social Responsibility) strategy. Novartis, for example, wants to be “completely plastic neutral, with all new products meeting sustainable design principles*” in 2030.

Conclusion
Starting early to discuss secondary packaging aspects can help you optimize manufacturing and stay flexible for upcoming demands. A holistic view supports your goal for a best possible interaction between primary packaging, secondary packaging and production while targeting a user centric solution. The resulting reliability and optimized machineability of your product have a positive effect on costs and time-to-market.

Such a holistic view requires a broad expertise and an early involvement of all stakeholders, whether they are internal departments or external partners. An experienced partner with broad expertise in dealing with complex packaging solutions and a proven track record for various packaging formats can be a crucial competitive advantage. 

*https://www.novartis.com/our-company/corporate-responsibility/environmental-sustainability/waste, Abruf 04.09.2019