Issue link: https://www.e-digitaleditions.com/i/1468049
54 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m parenteral delivery. Timelines can be prolonged, budgets expanded, and outside know-how may be needed from the medical device world. Allot- ting the right resources upfront for these regula- tory subtleties will drive more efficiency and value along the road to commercialization. Account for overlapping complexities of form and function Combi ni ng a n i njec table med icat ion a nd a delivery device is a step with intricate, far-reach- ing technical implications for device selection, manufacturing processes, and the product supply chain. Upstream decisions about many aspects of a product's commercial profile can lead to unforeseen consequences and unexpected costs when it comes time to select and launch in a delivery device. Primary packaging choices, for example, can ultimately dictate component selection and man- ufacturing processes—such as when an autoinjec- tor that requires more advanced specs ends up limiting compatibility with assembly machinery. Similarly, decisions around secondary packaging can inf luence downstream steps in the workf low regarding label placement or measures to safe- guard against pre-activation. Basic fill/finish parameters like viscosity and filling volume can also have domino effects. For instance, dose volume may dictate the length of the plunger rod in safety devices, while viscosity (and actuator strength) may limit appropriate autoinjec- tor options. In all these cases and more, delivery devices demand a holistic, forward-thinking ap- proach that accounts for multiple stages of a far more complex commercial manufacturing strat- egy—one that may need to factor in parameters from formulation all the way to packaging, fulfill- ment, and testing. Incorporate environmental stewardship With the global threat of climate change weighing heavily on public and private organizations, sus- tainability is rapidly reshaping the competitive vi- sion for the world's top industries. That includes the pharmaceutical sector, which contributes a large share of the planet's emission intensity, higher even than carmakers (4). Environmental initiatives can inf luence a com- pany's launch of a new delivery device in several ways, from limiting the use of certain raw ma- terials such as traditional plastics to working with production partners that embrace alterna- tive energy to power their operations. Drug de- velopers are increasingly building "green" goals into their new product profiles, through product attributes like multi-use delivery or minimized disposables—demands that manufacturers must then address in their production requirements. While these new trends aren't unique to the market for injectable medications, they can fur- ther raise the bar for organizations assessing the best combination of characteristics to help their product stand out in a crowded and increasingly eco-conscious market. But as scientific innova- tion and environmental stewardship increasingly align across the industry, proactively planning for a planet-friendly supply chain will invariably pay off in the short- and long-term. Combination Products Environmental initiatives can influence a company's launch of a new delivery device in several ways.