On Demand: GRAM Endpoints Manufacturing Day Webinar
On Demand: Key Factors, Critical Insights, and Essential Expertise for Selecting a Cartridge-Based Drug Delivery Device
The strategic partnership between Grand River Aseptic Manufacturing and SHL Medical provides fill-finish services for the 5 mL RTU cartridge used in the Maggie 5.0® autoinjector—the benefit to pharmaceutical organizations: An established supply chain and faster market entry. In this webinar, the two companies discuss considerations for selecting a CDMO and a drug delivery device.
- Does the drug delivery device meet the user’s needs?
- The requirements of patients guide the device selection process to ensure that the device meets user needs. Understanding the specific requirements of your filled drug product and the impact it has on your chosen device technology is helpful to discuss early. Bubble size, for example, can impact both manufacturing processes and patient dosing accuracy.
- Is the CDMO’s equipment compatible with the primary container?
- A CDMO’s experience with the size and type of primary components plays a critical role in the selection process. Leverage a CDMO’s available data for the primary components to ensure seamless integration during manufacturing. Factors such as the type of stoppers (RTU vs. RTS) and the corresponding sterilization methods must be taken into consideration. Collaborating with a CDMO that possesses line data, change parts, and in-house experience streamlines the process.
- Filling cartridges is distinctly different from filling vials.
- For example, the transition to RTU tubs eliminates certain manufacturing steps while introducing new challenges connected to robotics, such as denesting and renesting. The choice between mechanical and vacuum stoppering is influenced by factors like bubble size, viscosity, and stopper coating. Techniques such as delidding and delining are crucial for reducing particle generation in isolators, necessitating careful formulation adjustments and consideration of sterilization methods.
- Select partners with established operational relationships and a proven track record of successful project execution.
- GRAM’s deep sterile filling expertise tailored to diverse client needs, combined with SHL Medical’s expertise in developing innovative drug delivery solutions, creates a streamlined solution that offers significant value to pharmaceutical companies and ultimately, patients. The ongoing evolution in drug delivery device development emphasizes the need for a comprehensive understanding and careful planning at each stage, from selecting primary containers to ensuring effective manufacturing processes and addressing user needs through innovative designs, like the Maggie 5.0® autoinjector.
Hear more from the experts.
GRAM is eager to bring our large-volume cartridge filling expertise to market in collaboration with SHL Medical, and we are committed to supporting our clients’ products with precision and excellence. In October 2025, Grand River Aseptic Manufacturing’s sterile filling technology will have change parts installed and will be ready to fill the 5 mL cartridge used in SHL Medical’s Maggie® 5.0 autoinjector.
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