In the injectable drug-delivery industry, expectations for improved patient experiences with administration and at-home delivery of therapeutic regimens are evolving. Products that combine the drug, its primary packaging, and a delivery system — commonly called combination products — are on the rise. The inclusion and expansion of digital elements in a delivery system can help deliver medical, sensor, and diagnostic information in real-time data streams. Such data can help caregivers provide better overall care, while other digital elements may encourage adherence to therapeutic regimens. Given these trends, additive manufacturing (AM) provides the opening for expansive idea generation and development agility that can lead to improved quality and new opportunities to disrupt the drug-delivery space.

3D printing models of the SmartDose drug-delivery platform. (Credit: West)

AM, also known as 3D printing (3DP), is the process by which material is joined or solidified layer by layer under computer control into a three-dimensional object. Most commonly known for its use in prototyping, it also has manufacturing applications for the development and fabrication of fixtures and tooling for finished parts. AM technologies are also capable of creating complex final part geometries that are not possible through traditional manufacturing practices, such as injection or compression molding. Beyond the functional and tactical benefits, AM can have positive cultural impact by expanding how people approach problems from design through manufacturing. Wide access to and awareness of AM has the potential to tap into latent creativity within an organization by enabling the design-thinking mindsets of “bias toward action” and “embracing experimentation” that are critical to an innovation culture.

The Methods

AM is not a single technology, but rather a grouping of related technologies. Each type has different methods of layer manufacturing that need to be well understood to maximize their effectiveness and application within and organization. ISO/ASTM 52900 – “Additive manufacturing – General principles – Terminology” classifies the range of AM processes into these seven categories.

  • Binder Jetting

    • Liquid bonding agent is applied to thin layers of powder in a bed of material using inkjet-like print head. Typically requires secondary sintering process for metal or ceramic materials.

  • Direct Energy Deposition

    • Laser or electron beam energy is used to heat and fuse metal powder or wire-fed material as it is deposited in layers.

  • Material Extrusion

    • Material filament is heated and extruded onto a platform.

    • Examples: Fused deposition Modeling (FDM™), Fused Filament Fabrication (FFF).

  • Material Jetting

    • Liquid resin is deposited onto platform as droplets and cured via UV lamp. If multiple print heads exist, prints can be done with multiple materials.

  • Powder Bed Fusion

    • High powered lasers fuse powdered material together layer by layer. Non-fused powder surrounding the part acts as support.

    • Examples: Selective Laser Sintering (SLS™), Selective Laser Melting (SLM™).

  • Sheet Lamination

    • Sheets of material are stacked and fused together to form an object. The final shape of the object is achieved by cutting each layer with a knife or laser and removing the unneeded portions.

  • Vat Photopolymerization

    • Liquid photopolymer in a vat is selectively cured via laser or projected light.

    • Examples: Stereolithography Apparatus (SLA™), Continuous Liquid Interface Production (CLIP™).

With more than 25 printers across the seven categories in West's global network, AM methods are being used every day to support development and production of proprietary devices and systems, as well as provide contract manufacturing customers innovative options. While each of the different techniques has benefits and challenges, the capabilities have helped to expand possibilities and create new opportunities around drug delivery and administration.

Used in conjunction with the development process, all AM technologies have the potential to compress timelines by enabling faster experimentation and providing greater agility to change direction of a design when compared with options that rely on subtractive methods. AM can help to improve quality through new chemistries and materials, or by changing the manufacturing approach to enable mass customization at a production scale. Finally, AM provides new opportunities when combined with generative designs that allow more iterations to be completed in silico and built quickly for evaluation and large-scale production.

Creating a Culture of Innovation

At West, development teams and many others have access to different categories of printing technologies at their location or through internal channels. (Credit: West)

Wide access and increasing awareness of 3DP/AM technologies beyond pockets of “expertise” can grow innovation culture by expanding many people's understanding of what is possible. Broad knowledge of printing capabilities enables exploration potentially disruptive ideas or potential solutions by alleviating early constraints around timing and cost associated with traditional development production activities. At West, for example, development teams and many others have access to different categories of printing technologies at their location or through internal channels. They can pursue ideas quickly and cheaply that previously may not have been considered. This lowered risk in time and cost encourages more open ideation and exploration of new possibilities. With an approach towards AM that highlights applications in product development, production, and functional support linked via a community of practice, any company can create a more innovative culture.

Product Development. The first application for AM in most organizations is in rapid prototyping to support product development. Applications can range from using the simplest material extrusion style printers to get basic form factors to evaluate dozens of concepts quickly to highly post-processed vat-polymerized parts that look almost identical to end-use devices. Not limited to just outer geometries and shapes, clear materials and post-processing methods can be used to quickly evaluate new configurations of primary containers that may reside within a delivery device prototype. Printed components can also be used to leverage other rapid prototyping techniques such as vacuum forming for secondary packaging development. If end-use materials are needed, several metallic and non-metallic powder bed fusion technologies have the ability of producing short-run tooling that can be used in traditional injection or compression molding operations.

Production. Not just for small-scale prototyping and custom parts, AM technologies are increasingly capable of producing end-use parts at scales and quality levels that make sense for manufacturing. As material availability and printing precision increases, it will be important to consider whether products or components can be additively manufactured. AM production creates the possibility of mass customization and production agility. Opportunities also exist to include unique product features such as complex geometries that can achieved through no other method of manufacturing. To stay at the leading edge, organizations should be asking, “How might we incorporate AM parts into current and future products?”

Support. Use cases exist for AM beyond just prototype creation and end-use production. For example, most of the AM categories can be used to prototype, refine, and produce fixtures and jigs for assembly or inspection operations. Instead of creating a design and waiting days or weeks for a metal fixture to be evaluated, several designs can be printed on demand for quick evaluation. The best design can be efficiently determined, refined, and then released to final production through standard processes or possibly remain as an AM component. The same process and approach are applicable for laboratory fixtures and setups. As teams and individuals begin using AM for support needs, it is likely that they will see further applications that will increase speed and reduce costs.

Developing a Community of Practice. To further encourage use and knowledge of 3DP and AM, companies should consider developing an internal community of practice (CoP) focused on the technologies and their application within the organization. A focused CoP can help to quickly expand an organization's capabilities and collective knowledge. It can also foster a more open approach to ideation and application by providing a virtual space to collaborate, share experience, and facilitate access to AM resources and expertise.

Linking global AM experts and interested individuals from around the globe via an internal social network encourages the community to share ideas, develop best practices, and collectively work on issues and challenges. This has also made it easier to track the rapidly evolving technologies as community members share and discuss news, articles, and information. At West, the community is not limited to experts but has features specifically developed to help anyone learn about AM technologies and how they are being used across the organization.

As AM use expands, the company is leveraging it to develop new and disruptive solutions — much in the same way it did over 90 years ago, when founder Herman O. West reimagined rubber formulation development to enable the delivery of insulin. As the team continues to experiment and practice with the technology, they are building the skills to question what the technology can do now and in the future as capabilities in dimensional precision, printing speed, and material availability continue to advance.

This expanding set of AM technologies and capabilities is helping the organization reimagine the way it packages and delivers drug products. By expanding access to and knowledge of the technologies, it is fostering an experimentation mindset that builds upon our legacy of innovation that will ultimately correlate to more ideas and better solutions for customers and patients.

This article was written by Chris Evans, Vice President, Innovation, and Christian Eichhorn, Director, Innovation Management, West Pharmaceutical Services, Inc., Exton, PA. For more information, visit here.