Grand River Aseptic Manufacturing’s Strategic Partnerships
Grand River Aseptic Manufacturing and leaders in advanced drug delivery devices are evolving their relationships to serve pharma and biotech into the future.
The development of a drug combination device cannot be conducted solely by a CDMO. It requires specialized expertise from professionals well-versed in their respective fields. From the perspective of sterile filling, the process is considerably more complex due to regulatory considerations that encompass both drug and medical device regulations. Complexity increases because the filling process directly influences device performance, including resistance, fill levels, and bubble size. These elements require greater precision and tolerance.
Cultivating Excellence
CDMOs are uniquely positioned to facilitate the development of new drugs and the concurrent commercialization for multiple clients, enabling them to cultivate expertise that supports rapid technology transfers and the efficient scaling of production. Fostering a strong relationship with the device’s developer is essential to the successful realization of the product. Drug ecosystems excel in their individual domains; however, true innovation is achieved through collaborative efforts that challenge existing boundaries. This collaboration allows pharmaceutical companies to focus on their strengths while relying on the specialized expertise and collaboration of CDMOs and drug-device companies to address their manufacturing challenges.
Our partnerships provide unique value beyond conventional CDMO services by accelerating the development of syringe and cartridge filling and finishing solutions for our partners’ innovative autoinjectors and on-body delivery systems. These partnerships break down barriers in the drug delivery ecosystem by combining our expertise in advance. Strong relationships form the foundation of these partnerships, which give us specialized knowledge in understanding client solutions for autoinjector and on-body delivery designs as they evolve.
Together, we provide a comprehensive solution for developing and manufacturing devices to deliver biologics and put patient care first.
LTS and Grand River Aseptic Manufacturing form strategic alliance for sterile fill-finish of Sorrel™ wearable injector containers
- On-body devices provide an essential solution in patient care. LTS’ Sorrel is the next-generation wearable device for large-volume drug products designed for patient convenience. As you decide on your device, an important question arises: Where might the cartridge be filled? GRAM provides a solution to that question. We have the unique experience of filling large-volume cartridges today.
- Our partnership supports the client’s journey with an end-to-end solution for pre-loaded and pre-filled containers. Product development and commercialization are streamlined, allowing for faster market access and production. GRAM’s expertise in aseptic manufacturing capabilities for biologics and varying equipment capacity support scalable solutions.
SHL Medical and Grand River Aseptic Manufacturing forge strategic partnership to offer fill finish services for RTU cartridge used in Maggie 5.0® autoinjector
- Pharmaceutical organizations now benefit from an established supply chain and faster market entry for the Maggie® 5.0 autoinjector. Maggie® was developed to open new pathways for handheld devices to accommodate a wider variety of formulation characteristics that were not possible with prefilled syringe-based autoinjectors.
- By combining SHL’s expertise in developing innovative drug delivery solutions and GRAM’s expertise in filling and finishing for diverse client needs, we are creating a streamlined solution that will offer significant value to pharmaceutical companies and, ultimately, patients. Our collaboration introduces GRAM’s services for filling the cartridge used in the Maggie® 5.0 mL.
The dedication to developing innovative drug delivery devices to improve patient care aligns seamlessly with our patient-centered culture and commitment to the success of our customers’ impactful therapeutics. We welcome discussions regarding our partnerships and how best to support your product.
BD and Grand River Aseptic Manufacturing announce fill-finish services supporting the BD Libertas™ Wearable Injector
Through the strategic alliance between GRAM and BD, we have successfully established 5 mL and 10 mL cartridge fill-finish capability for the BD Libertas™ Wearable Injector.
- 5 mL and 10 mL programming created and qualified
- Vacuum-assisted stoppering capability established
- Multiple production runs completed successfully
- Ready to support customer programs utilizing the BD Libertas platform
The BD Libertas™ Wearable Injector is designed to help pharma transition therapies from IV to subcutaneous administration and simplify delivery of high-dose subcutaneous drugs where the drug delivery solution needs to address delivery time or tolerability objectives. Together, this milestone strengthens the infrastructure available to pharmaceutical innovators developing next-generation biologics requiring convenient, high-volume and high-viscosity subcutaneous delivery. We’re excited to help customers move faster from development to commercialization with an integrated fill-finish and wearable injector solution. Contact us to learn more about how this partnership is shaping the future of biologic therapies and empowering patients worldwide.
