Enriching Sterile Fill-Finish Services
PharmaNetwork Article: June 2025 Issue
Grand River Aseptic Manufacturing’s Patient-Centric Approach
Aseptic manufacturing is a crucial aspect of the life sciences industry, especially as demand for complex biologics and biosimilars continues to rise. This manufacturing process, which ensures sterility in the production of pharmaceuticals, is undergoing significant advancements fueled by technological innovation and a growing emphasis on patient-centric delivery systems.
As the industry shifts toward biologics and biosimilars, manufacturers face the challenge of working with complex formulations that are subject to stringent regulatory requirements. The need for experienced Contract Development and Manufacturing Organizations (CDMOs) has never been more vital, particularly those that adhere to the latest regulatory guidelines, such as Annex 1, focusing on isolator technology and contamination control strategies to maintain product integrity and quality control in sterile environments. CDMOs must proactively adopt best practices to remain compliant and competitive through a continuously evolving regulatory landscape.
As patient comfort and convenience become increasingly prioritized, the demand for fill-finish services of pre-filled syringes and cartridges has surged. Aseptic filling of the primary container plays a pivotal role in ensuring that these patient-centric delivery systems reach the market. Subcutaneous (sub-q) delivery methods are transforming patient experiences by enabling self-administration of treatments at home and reducing the frequency of clinic visits—an advantage for individuals managing chronic conditions. This shift in patient-centricity and drug administration methods highlights the need for flexible manufacturing solutions to accommodate drug delivery innovations and custom product specifications.
The importance of aseptic manufacturing partnerships cannot be understated as the life sciences industry continues to evolve and better serve patients. With a greater focus on complex formulations and patient-centric delivery systems, CDMOs must adapt and provide enriched services driven by patient-centricity. Grand River Aseptic Manufacturing leverages its technological advancements and fosters strategic partnerships to remain at the forefront of providing safe, effective, and innovative pharmaceutical products that serve patients around the globe.
Adapting to industry shifts
The growing complexity of biologics and global distribution requires Grand River Aseptic Manufacturing (GRAM) to adapt quickly to industry shifts, which, after the COVID-19 pandemic, required a pivot to biologics and more complex formulations. GRAM now handles larger, globally distributed products, which has increased contact with many international regulatory agencies. Investments in new facilities and stringent containment protocols during and after the pandemic ensure a CDMO is favorably positioned in an ever-evolving industry. Strengthening facility designs for aseptic processing and environmental monitoring helps meet evolving regulatory requirements, like Annex 1, and international standards, guaranteeing the safety and quality of products worldwide.
Demand for faster time-to-market has intensified. CDMOs with established core competencies protect their expertise and advance swiftly with changes in demand. GRAM concentrates on sterile filling and finishing processes that allow for quick adaptation without sacrificing quality or reliability. Streamlining operations enables CDMOs to meet the fast-paced demands of the market.
Looking ahead, GRAM will continue to support larger and more complex products. Recent investments in facility expansions, like a new state-of-the-art syringe and cartridge filling facility, reflect a commitment to serving pharma and biotech clients into the future. Their expansions align with a shift toward a project-focused culture, allowing GRAM to better support more tech transfers and attract new projects. This growth has significant recruitment advantages, drawing engineers and technicians eager to work with the latest systems. GRAM is creating new opportunities for both its team and clients, particularly in the biologics sector.
For GRAM, adapting to industry shifts also included the recent installation of an eight-head Bausch+Ströbel vial filler with a SKAN isolator to increase vial capacity. All four of GRAM’s filling lines are equipped with isolator technology, which is a game-changer, especially regarding Annex 1 compliance. Isolator systems are more stringent than the simpler barrier systems used previously, as they physically separate operators from products, utilizing glove ports and automated systems for access. This significantly reduces contamination risks and enhances confidence in aseptic filling, making it a crucial improvement for handling sterile injectable products. GRAM’s expansions support longer production runs, accommodate more specialized devices, and meet the shift in rising demand for biologics.
Fostering strategic relationships in drug delivery
The life sciences industry is increasingly prioritizing patient-centricity, leading to growth in self-administered drug delivery systems. There is significant progress in discovery, patient-focused delivery options, and prioritizing the patient experience. Self-administration methods, including autoinjectors and wearable devices, are essential for enhancing patient comfort and outcomes, particularly as more care moves into the home setting and treating chronic and rare conditions requiring regular injections. GRAM has adopted a collaborative approach to filling the primary container for drug delivery systems, further enriching the services it provides.
Establishing strategic partnerships between CDMOs and drug delivery device providers can bridge gaps in the supply chain, enhance customer experience, and ensure the effective and safe delivery of products. Early discussions in the production process enable CDMOs to adapt their manufacturing approach to the specific needs of the drug delivery system. Bringing stakeholders together early on leads to a greater chance of successful outcomes. A collaborative mindset fosters innovations centered around patient care and enhances the effectiveness of drug delivery solutions.
GRAM and leaders in advanced drug delivery devices are evolving their partnerships to better serve the pharmaceutical and biotech industries. These collaborations help eliminate barriers in the fill and finish processes for syringes and cartridges associated with novel drug delivery devices. The emphasis on innovation underscores the importance of agility in manufacturing. Flexibility in equipment and expertise allows CDMOs, like GRAM, to respond swiftly to market demands. As the healthcare landscape evolves, CDMOs must prioritize patient-centric strategies to drive meaningful advancements in drug delivery systems.
As patients become more active participants in their healthcare, CDMOs can play a greater role in providing for the end patient. To do this, GRAM has positioned itself as a strategic partner to help accelerate market entry for its customers. The collaboration between the CDMO, drug delivery provider, and the pharma company is taking the spotlight when determining who will fill and finish a drug product. Partnerships characterized by transparency and mutual learning bring all parties towards a common goal and address challenges openly to create successful products. These partnerships ensure alignment to reach each other’s goals. If objectives do not match, partners explore how to move forward as a unified team rather than as separate entities. By maintaining open communication and collaborating toward a shared goal, all parties can achieve success, ultimately benefiting the patient.
Strategic Alliances Announced:
- LTS and Grand River Aseptic Manufacturing have formed a strategic alliance for the sterile fill-finish of Sorrel™ wearable injector containers. LTS’ Sorrel is the next-generation wearable device for large-volume drug products designed for patient convenience, and GRAM has the unique experience of filling large-volume cartridges today.
- SHL Medical and Grand River Aseptic Manufacturing have established a strategic partnership to provide fill-finish services for the RTU cartridge used in the Maggie 5.0® autoinjector. 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.
The importance of primary containers in drug delivery
When you encounter a wearable device, a pen, or an auto-injector, the primary container that holds the drug product is crucial. It is important not to overlook that primary container. When collaborating with a device company or considering a new device, it is helpful to think about what the syringe is like on the inside, what stopper will be used, how each element works together, and who will be responsible for the filling process. If you have a syringe and a stopper in mind, you need to ensure that you have a partner with the right capabilities to fill it. If a device manufacturer is not working directly with a CDMO, they might face a steep learning curve once the project progresses—it is better to have these conversations up front.
Viscosity is important when considering the right primary container. Delivering a viscous product to a patient only works if a CDMO can fill that viscous product into the primary container. If a device company opts to create a custom primary container that perfectly fits their device but does not consult with a CDMO early in the development process, they may encounter significant delays. If they bring the design to the CDMO too late, special parts may be needed to accommodate the filling, which could extend timelines. There are many discussions surrounding new primary containers, such as 10 mL and 20 mL options, and early communication is vital.
More often, pharma and biotech companies need a higher-volume CDMO capable of filling their products into larger primary containers while simultaneously managing the requirement for a more viscous product. These needs are causing a shift towards syringes or cartridges rather than vials to facilitate home delivery. Drug product delivery is moving away from 1 mL or 2 mL syringes to using a 5 mL primary container.
Biologics tend to be expensive to manufacture, and the drug substance itself is often challenging to produce. Consequently, pharma and biotech companies are providing CDMOs with batch sizes ranging from 100 liters to 200 liters, which contrasts with small molecules that might require batch sizes closer to 500 or 1,000 liters. Effective cold chain management is critical for the handling of biologics. Pharmaceutical companies have strict requirements for maintaining the integrity of the molecule throughout the cold chain process. CDMOs must have the capabilities to manage the drug substance at -80°C and maintain this temperature throughout manufacturing, inspection, and packaging.
Procurement or alliance teams typically bring opportunities to CDMOs. Now, CDMOs are being involved earlier in discussions and engaging with the development team from the start. Early collaboration is beneficial because it allows all teams to address potential issues before they become problems. Asking questions and seeking expertise between the pharma company, CDMO, and drug-device delivery company is a significant evolution compared to the traditional model, where pharmaceutical companies would develop a process and then hand it off to a CDMO without any prior consultation.
Transparency amongst partners is imperative for a patient-centric approach. At GRAM, when comparing their approach today to what they did ten years ago, transparency stands out as a significant change. In the past, pharmaceutical companies may not have felt comfortable sharing the hurdles they faced during production. The collaboration was often limited to transferring information and responsibilities. Now, GRAM has regular, open discussions with our clients, effectively becoming part of their teams. This heightened transparency allows teams to share insights into mutual challenges and collaborate more effectively to ensure their products are delivered on time and to specifications.
As part of adopting this transparency, GRAM and its partners are signing confidentiality agreements that involve multiple parties, such as the client, the CDMO, syringe vendors, and container closure vendors. These agreements facilitate open communication among everyone involved, allowing effective strategizing for successful product outcomes. Communication, coordination, and collaboration are key to all parties achieving their goals.
About Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing (GRAM) is a leading contract development and manufacturing organization (CDMO) specializing in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges. GRAM is committed to advancing patient care by providing our clients with the experience, technology, and quality record necessary for effective clinical trials and successful commercialization. As a strategic partner to biotech and pharma companies, GRAM helps bring breakthrough innovations to the market through flexible and scalable fill-finish services. GRAM’s track record of successful tech transfers and equipment initiatives has prepared its team for more complex projects, ultimately advancing its mission of efficiently bringing life-saving products to the market.
GRAM adds value to our clients through strategic partnerships with innovators in drug delivery devices, offering tailored solutions designed for autoinjectors and on-body delivery systems. Their emphasis on collaboration allows them to speed up the delivery of innovative therapies, ensuring that our clients’ products reach the market and benefit patients into the future.