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Q&A Injectable Drug Delivery Trends

Grand River Aseptic Manufacturing (GRAM) is a premier provider of injectable drug delivery solutions, specializing in sterile manufacturing and complex drug formulations. With state-of-the-art facilities and a commitment to quality, GRAM delivers innovative and reliable services across various stages of drug development and commercialization. Their expertise spans from small-scale clinical batches to large-scale commercial production, integrating cutting-edge technology with stringent regulatory adherence.

Contract Pharma recently interviewed GRAM’s senior business development manager, Mary Lou Glotzbach, about current trends and challenges in the injectable drug delivery space, particularly how the shift towards self-injection has led to innovations in on-body devices and auto-injectors.

 

Contract Pharma: What emerging trends are you seeing in the drug delivery space, particularly concerning on-body devices, auto-injectors, syringes, and cartridges?

Mary Lou Glotzbach: Large pharmaceutical and biotech companies are currently focusing their teams on researching drug delivery devices to better understand evolving technologies and corresponding patient needs and preferences. Self-injection is poised to become the standard for many new and existing medications. The crucial question at hand is what is truly best for the patient. Determining the most effective approach to deliver the larger injection volumes associated with many biologics is paramount. Companies must determine whether patients will be comfortable utilizing two auto-injectors for larger volume requirements or if an on-body device would be more suitable for this population. It is important to note that there will be multiple device solutions, and it is the priority of most major companies to identify a platform technology that can cater to the majority of their self-injection portfolio.

CP: How are on-body drug delivery devices evolving, and what role does Grand River Aseptic Manufacturing (GRAM) play in the future of these devices?

Mary Lou: When assessing on-body devices, a pharmaceutical company must thoroughly evaluate multiple performance features. These include determining whether the drug cartridge will be user-loaded or preloaded and preassembled in the device, specifying the required volume range for delivery, deciding on connectivity options, and choosing between battery-powered or non-battery-powered devices. Additionally, single-use sustainability must be taken into account. The development of multiple device solutions with varying capabilities can pose challenges for the contract development and manufacturing organization (CDMO) responsible for the aseptic filling of the primary container. GRAM’s proactive solution involved investing in a modular fill line, the Bausch+Ströbel VarioSys, to provide the team with the flexibility to offer clients various solutions. For example, the line fills smaller volume syringes for auto-injectors along with larger volume cartridges used in on-body devices.

 

 

CP: Auto-injectors are becoming increasingly popular due to their ease of use. How is GRAM adapting its capabilities to meet the growing demand for auto-injectors?

Mary Lou: GRAM offers aseptic filling services for the primary containers used in auto-injectors, which predominantly consist of syringes. Recognizing the industry trend towards larger volume primary containers, we have partnered with drug delivery experts to offer filling services for these containers beyond the typical 1mL or 2.25mL syringes. To further support the growing demand for syringe and cartridge fill-finish, GRAM made a substantial investment in a new syringe and cartridge filling facility and fill line. This expansion will significantly increase our capacity to cater to the syringes used in the majority of auto-injectors today and in the future.

CP: What are the latest innovations in syringe and cartridge manufacturing, and how is GRAM positioned to support these advancements?

Mary Lou: Many of the manufacturing improvements are related to the equipment used for filling drug products into syringes or cartridges. GRAM has invested in two lines that offer different solutions. Our modular line offers the flexibility to run small to medium batch sizes of syringes or cartridges, while our new line will expand our capabilities to handle larger batch sizes. The streamlined and linear design of our new line results in accurate and efficient filling, check-weigh, capping, and reloading into the syringe nest. This line also incorporates a 100% weight check, ensuring greater consistency in delivered volume. In addition to filling capabilities, GRAM’s enhanced offerings will include innovative solutions for automated visual inspection, syringe assembly, and packaging.

 

 

CP: Can you discuss the importance of customization and flexibility in drug delivery solutions and how your company ensures it meets diverse client needs?

Mary Lou: Studying human factors is crucial when selecting the device to deliver a medication. To ensure our clients are confident in their drug delivery solution, GRAM has taken a proactive stance, choosing to collaborate closely with clients and device manufacturers to offer a diverse range of solutions, whether a small volume syringe or a large volume cartridge. Furthermore, GRAM has significantly invested in additional packaging lines to offer highly flexible design layouts for secondary packaging.

CP: Looking ahead, what are your predictions for the future of drug delivery technologies, and how is GRAM preparing to stay at the forefront of these developments?

Mary Lou: The demand for self-administration will continue to grow. Device solutions will evolve with patient needs, and manufacturing solutions will unquestionably follow. GRAM proactively collaborates with suppliers of commodities, devices, OEMs, and the pharmaceutical and biotech industry to learn and adapt to the imminent advancements. GRAM is an incredibly dynamic organization that swiftly adapts to remain at the forefront, consistently offering unparalleled solutions.