Insights from the Top: An Exclusive Interview with Derek Hennecke, CEO of Grand River Aseptic Manufacturing
What are the recent updates and milestones at GRAM?
After the COVID-19 pandemic, we pivoted to biologics and more complex formulations. We are handling larger, globally distributed products, which brings us into contact with many different international regulatory agencies. A significant development is the revised Annex 1 guidelines in Europe, requiring new facilities and stringent containment protocols. Our investments during and after the pandemic positioned us well.
How will GRAM’s expansions affect operations and enable new synergies for clients?
We expanded GRAM’s inspection, finishing, and warehouse center in 2024. In 2025 we will continue to support larger, more complex products, which brings us to our current syringe and cartridge filling facility expansion. These two facilities form a campus near the airport that includes capabilities for syringes, finishing, and packaging. GRAM’s expansions align with our shift toward a project-focused culture, supporting more tech transfers and attracting new projects from large pharma companies. Our growth and recent expansions are a big recruitment advantage, as they draw engineers and technicians to work with the newest systems, creating fresh opportunities for both our team and clients, especially in the biologics space.
Additionally, we recently installed an eight-head Bausch+Ströbel vial filler with a SKAN isolator and expanded our vial capacity. GRAM’s four filling lines are all equipped with isolator technology, which is a game-changer for the industry, especially as it relates to Annex 1. Isolator systems are more stringent than the simpler barrier systems used previously, physically separating operators from products and using glove ports and automated systems for access. This not only reduces contamination risk but also boosts aseptic filling confidence, making it a critical improvement as we handle sterile injectable products.
These expansions enable us to handle longer production runs, accommodate more specialized devices, and meet the increasing demand in biologics.
How has GRAM adapted to changing demands from the pharmaceutical industry and the global regulatory landscape?
The growing complexity of biologics and global distribution required us to adapt quickly. We have strengthened our facility designs for aseptic processing and environmental monitoring to meet evolving regulatory requirements, like Annex 1. These efforts ensure that we meet international standards, guaranteeing the safety and quality of products worldwide.
The demand for speed-to-market has intensified, especially post-COVID. We streamlined our processes. Our relatively smaller size and focus on sterile fill and finish allows us to adapt quickly without compromising quality or reliability, and we are committed to meeting the fast-paced demands of the industry.
We see a shift towards prefilled syringes and cartridges for autoinjectors and wearable devices, enabling patients to manage treatments at home rather than in a clinic. We are seeing a transition from intramuscular to subcutaneous delivery.
How has the focus on patient-centricity impacted the industry?
Patient-centricity is dominating the industry, leading to a rise in self-administered drug delivery, particularly for chronic and rare conditions that require regular injections. Self-administration, using autoinjectors and wearable devices, is essential for these patients. This shift toward at-home care paired with precise dosing is crucial for improving patient comfort and outcomes. It directly influences our approach to drug delivery systems.
What success story demonstrates GRAM’s expertise?
A notable example is a project with a major pharmaceutical company that required daily administration of large volumes. The scale and rapid pace required us to almost double our Manufacturing Science and Technology (MSAT) personnel and adapt quickly. Our ability to redesign processes and meet tight timelines was critical to the success of this project.
How does location contribute to GRAM’s competitive advantage?
Operating in the Midwest provides us with a stable environment characterized by low turnover, allowing us to maintain a skilled workforce with strong institutional knowledge. The region’s reliable work ethic enables consistent delivery of results. We leverage this stability while bringing in fresh talent from other pharmaceutical hubs, creating a powerful blend of experience and new perspectives that fuel our growth.
How are strategic partnerships shaping GRAM’s future in the evolving CDMO space?
We are focused on advancing patient-centered delivery systems through key partnerships with companies like SHL Medical and LTS. As the first fill-finish provider of the RTU cartridge used in SHL Medical’s Maggie 5.0® autoinjector, we are enabling subcutaneous administration of concentrated monoclonal antibodies, improving patient comfort, and enabling at-home administration. We are developing prefilled syringes and wearable devices to expand our capabilities.
Looking at the broader CDMO landscape, we believe service providers need to catch up with the rapid innovation in pharma and biotech. We are positioning ourselves as an inside partner for large pharma to accelerate market entry, and while there is still room for industry growth, our assets and team put us at the forefront of this evolution.
How do GRAM’s initiatives for 2025 align with the company’s mission?
We position ourselves as a strategic partner to biotech and pharma companies, helping them bring breakthrough innovations to market through flexible and scalable services. Our 2025 growth trajectory includes managing 15 simultaneous tech transfers and implementing significant equipment upgrades. This includes the Bausch+Ströbel vial filler that will double our processing speed to 400 vials per minute and constructing a new syringe filling facility. We strive to accelerate our clients’ market entry through trusted partnerships. With our track record of successful tech transfers and equipment initiatives, we are well-positioned to enhance our capabilities for more complex projects, ultimately advancing our mission of bringing life-saving products to market efficiently.
