“At its core, fill-finish involves taking a bulk pharmaceutical product – whether a vaccine, biologic, or small molecule – and precisely filling it into its final container for distribution. For some products, such as biologics, the complexity is amplified due to their sensitive nature. These treatments require highly specialised, sterile environments and precise handling to maintain their potency and safety. The demand for biologics, gene therapies, and cell therapies has rapidly accelerated, and so has the need for innovative solutions in f ill-finish packaging and manufacturing.” Emma Verkaik, CEO of the BCMPA – The Association for Contract Manufacturing, Packing, Fulfilment & Logistics
In the Summer issue of IPI, Emma Verkaik, CEO of The Association for Contract Manufacturing, Packing, Fulfilment & Logistics, writes, “The fill-finish phase in the pharmaceutical manufacturing industry is undergoing a significant transformation. Once primarily focused on the aseptic filling of vials and syringes, it has now evolved into a multi-faceted process requiring a high degree of technical precision, regulatory awareness and strategic foresight.”1 The need for the integration of final combination device assembly into the production process has heightened the importance of device design to achieve optimal production process efficiency.
Delivery device partners must align with current manufacturing priorities. As the pharmaceutical industry innovates and enables greater self-administration of more complex dosing regimens, it needs appropriate drug delivery solutions, capable of handling a range of formulation types.
Many therapies and their dose regimens can be accommodated by flexible and de-risked platform devices. New drug formulations need ever more flexible solutions – but developers have to square the circle while containing costs, and ensuring performance and ease of use. Additionally, with patient populations growing, manufacturing efficiency is key for cost effective global market access.
Typical Assembly Scenarios
Pharmaceutical manufacturers will be familiar with a scenario where one drug requires six different fill volumes, and two or three different types of autoinjector. In this scenario, the manufacturer modifies assembly processes for each autoinjector, adjusting pre-filled syringe filling and stoppering, for instance.
Each of these variants will require individual assembly process validation steps; this additional validation requirement drives significant operational and quality complexity and therefore costs. Optimised device design reduces the line change requirements between product variants throughout a manufacturing campaign, improving overall capacity utilisation.
Innovative biologic therapies further increase complexity. Batch sizes for these therapeutic products are inherently smaller and more variable, resulting in more frequent changeovers, with filling lines adjusted for each batch. Small batch variations can also impact device performance, specifically injection time and plunger force. Inherently flexible autoinjectors can therefore streamline assembly activities for innovative products in development, and support consistent performance.
