Streamlining Key Services Your Drug Delivery Device Partners Provide
With advanced drug delivery systems like auto injectors and pen injectors becoming an emerging trend for the pharmaceutical industry, such combination products will require close collaboration between the pharma and the device manufacturers.
This title may sound like a mouthful, but with advanced drug delivery systems like auto injectors and pen injectors becoming an emerging trend for the pharmaceutical company to deliver biologics in, such combination products will require close collaboration between the pharmaceutical companies and the device manufacturers. Taking the auto injector as an example of a combination product; a typical auto injector consists of a pre-filled syringe (PFS) or cartridge inside a device with enough mechanical force to fully inject the desired drug within the specified delivery requirements. As the key decision maker, the biopharmaceutical company will be the one that chooses the associated partners and delegate roles to each partner accordingly. These key areas can include the selection of the supplier of the primary container, the filling of the primary container and the device’s Design & Development, Manufacturing and Final Assembly & Packaging.
Ideally, to better ensure and supervise quality and minimize potential communication gaps, the biopharmaceutical company should partner with a device candidate that can offer a range of the services above in-house, especially since taking an auto injector from early design to being ready for mass production can be an extremely complex process. Just the development process only involves Planning, Design, Engineering, Process Validation and much more. Accurately implementing the input requirements (such as dosage, viscosity, injection time, activation methods, etc.) into the device design requires ongoing communication between the two parties and will need to ensure that the final device is manufacturable. It is a delicate balance, but the end-user needs should always be prioritized over the manufacturing process, so long as it does not affect the safety and effectiveness of the device. Regardless, the design of the device needs to be verified and undergo rigorous physical testing to prove the device has a proper mechanical sequence. To be able to produce different prototypes and SLA models to review and test, the device partner should also possess strong manufacturing capabilities in-house as well to perform related tasks in a timely manner.
Core capabilities such as Tooling, Molding, Automation, Assembly and Metrology are vital to manufacturing a high quality auto injector. Tooling and Automation are two areas that deserve special attention by biopharmaceutical companies as these capabilities are sometimes outsourced by device suppliers. Tooling is a significant expense in any drug delivery device program and lead times must be planned for carefully. For high volume projects multiple sets of tooling are needed for production, safety stock and risk mitigation. The intellectual property of new devices must be protected by strictly controlling who has access to these tools and related drawings. Taking tooling in-house is very costly for device suppliers, but can really help control quality and timeline concerns. In addition, having a capability like automation internally means that a device company can quickly build robust and flexible solutions for assembling and testing devices even while the design for the device is still being finalized. Certain tasks can be done in parallel and this will also increase response times.
Once the sub-assemblies of a device are produced the next step is integrating them with the biologic-filled primary container to create a completed combination product. Pharmaceutical companies basically have three options to consider at this stage: do final assembly themselves, outsource to a third-party, or find a drug delivery device partner that can provide this service. Ideally, the device supplier can offer final assembly, labeling and packaging services for devices to streamline the production and distribution process to improve end-product quality and speed-to-market for customers. From a quality and regulatory point-of-view, final assembly facilities should be ISO13485 certified and registered with FDA as a drug establishment, qualified to handle and distribute pharmaceutical products. Additionally, they should conform to all other regulatory requirements for medical device and pharmaceutical packaging and distribution, as per 21 CFR Parts 820, 210 and 211. The staff involved at this level will have both drug and device expertise to help ensure the safe production of the combination product. Thus, any company looking to bring a combination product to market should be looking for device partners that have the capabilities and processes needed to streamline the delivery of devices such as auto injectors.