Designing pharmaceutical packaging is sometimes perceived as a relatively minor consideration reserved for the end of the drug development process.
Yet, designing pharmaceutical packaging with an eye on manufacturability is critical for successful commercialization and should be an integral part of product development.
Choosing the right packaging partner is therefore essential for streamlining the process by way of ensuring compatibility with equipment trains, keeping labor and commercialization costs from escalating, and avoiding costly supply chain bottlenecks.
Designing for manufacturability must factor in patient centricity, equipment, materials, and budget constraints.
There are many considerations that go into pharmaceutical packaging. One of the most prominent is patient-centric design, which facilitates drug administration and supports patients’ adherence to a treatment regimen. However, there is a growing awareness that patient-centric design should not come at the expense of customizing packaging designs to the point where medicines cannot be packed using available equipment or need new equipment that can only be used for a single design.
That is where the design for manufacturability (DFM) concept comes in. If a product’s packaging design is aligned with patient-centric priorities—but is not optimized for the equipment the packaging process is going to run on—it can lead to upfront capital costs, modiﬁcations to existing equipment, and higher labor and commercialization costs, ultimately resulting in higher manufacturing costs. “None of us want to bring to market a package that, while it looks elegant, is not able to be commercially produced,” Kahle said.
DFM is developing or optimizing a design to its production process while meeting all patient and product requirements.
Pat Kelly, PCI Pharma Services
One approach to designing with manufacturability in mind is eliminating requirements that specify the exact materials to be used in packaging. Sometimes, manufacturers are locked into vendor agreements that include such requirements as part of standard operating procedures, and that diminishes their capacity for ﬂexibility and rapid response in case of supply chain issues that may impact lead times.
Making sure that the specifications that are being drafted for materials for packaging are generic and not brand-led may give [manufacturers] more flexibility.
Gary Orr, Perigord
Another way to optimize manufacturability is by considering package design early in the pharma product lifecycle. This helps companies understand and anticipate what the potential budget or assembly constraints are for a given packaging design and address them before manufacturing begins.
A common occurrence is when a client has a package designed by a third-party design agency, which may ﬁt the end user speciﬁcation but which then does not ﬁt on the packaging equipment itself when it comes to commercial manufacture. This results in costly delays and potentially the need to procure expensive equipment. By considering the package design during the late clinical phases and working with an in-house design team such as PCI’s, the ﬁnal commercial pack will ultimately adhere to all end-user speciﬁcations, ﬁt seamlessly onto the production lines, and get to market much sooner.
Pharma and biotech companies looking to optimize design packaging for manufacturability are grappling with multiple trends, requirements, and end-user expectations. In an era of persistent supply chain disruptions, life sciences companies can beneﬁt by breaking free from vendor agreements that limit their choice of materials and increase lead times, while keeping costs manageable and baking in sustainability throughout the packaging process.
To reach those objectives, it is crucial to move packaging considerations as far upstream in the product development process as possible. “A lot of people leave packaging to a later stage in the process—embed it in your stage-gate process to mitigate risks and allow yourself to scale quicker,” Orr noted.
Partnering with a packaging solutions provider that has subject matter expertise, internal and external networks, and a deep understanding of all of the steps involved in the process can ensure that those considerations take place at the right moments.
DFM is a very dynamic process and involves decisions that can’t be made in a vacuum.
Matt Kahle, PCI Pharma Services