No matter if it is meeting the needs of a rapidly aging market, blocking drug counterfeiters or differentiating your pharmaceutical product in the market, a secondary packaging program is essential to achieve success. However, pharma and biotech companies tend to focus their attention primarily on upcoming manufacturing scale-up and regulatory requirements when it comes to clinical phase III. Decisions in this phase can have a direct impact on the future of your drug product. But what is the best starting point to begin creating a strategy for secondary packaging? We think it is when the choice for the primary packaging is about to be made. In secondary packaging, as in all complex projects: Start with the end in mind:
• Take a holistic and early view as a key success factor
• Consider the strong interdependence in the pharmaceutical field
• Look for broad expertise and early involve all stakeholders
The following considerations are important when it comes to developing a secondary packaging strategy for injectables.
The effects of primary packaging
There is no doubt that the choice of a primary packaging has massive effects on secondary packaging. For example, if you think about combining your syringe with an auto injector or safety device, the assembly machine needs to be able to handle the primary container. Moreover, the syringe should be designed to resist higher mechanical forces. When launching a drug in an auto injector, even when setting up on an existing platform, studies are required and extra time for device customization must be considered.
There are a couple of regulatory challenges that can affect secondary packaging. For example, additional market approval and documentation demands for more sophisticated solutions such as auto injectors can affect the timing. As a service provider, we often face customers that plan to launch several variants, like syringe and auto injector, at the same time, essentially resulting in a staggered market launch. Country specific regulatory requirements, e.g. additional labels or mandatory variable data, can also place demands for extra space on the packaging itself.
Due to the different country and packaging variants, a previous big batch size in filling often melts down in many different saleable units in secondary packaging. Therefore, a dedicated launch and supply chain strategy will contribute to an expeditious time-to-market.
As drug products have differing indication specific requirements, usage can have wide variations. For example, handling ophthalmic syringes utilized in a professional setting are quite sensitive and differ significantly from syringes for home use such as drugs for arthritis. Also, age and educational level impact the drug administration. The best possible solution is clearly focusing on the administration use case.
Planning extra time for differing country/market specifics will also be important. It is important not to underestimate the internal approval process and extra time needed. For example, in creating and getting approved differing artwork for multi-country/market labels and booklets.
The reimbursement landscape can impact your market approach and secondary packaging solution
Competitive differentiation is a key
A deep understanding of target groups will build a solid opportunity for successful differentiation against competition – supporting life cycle management from launch to the later stages of a product’s life cycle. It is important to consider customer convenience and product usability which relate to adherence and patient safety. Don’t forget that convenience and enhanced user experience can be contradictory with simplification in production/assembly and market approval. Enhancing drug delivery in terms of reliability and convenience can be valuable drivers for an active product lifecycle management strategy and help differentiate the product in the market.
Changing markets and regulations may require a rethinking of a compound’s secondary packaging. In many cases, a secondary packaging program that is well-conceived from the start allows drug products to meet the challenges of diverse global markets. A highly qualified Contract Development and Manufacturing Organization (CDMO) with significant expertise in dealing with complex packaging solutions can safeguard the product’s quality throughout the packaging process. As a global partner, Vetter has great experience in developing and implementing secondary packaging and offers its customers a broad spectrum of services. Beginning with the end in mind should be your first step in the journey of creating an effective packaging strategy.