Insights from GRAM at CPHI Milan 2026: Navigating the Future of Sterile Manufacturing

September 9, 2026

What to Expect

As biologics manufacturing evolves, Contract Development and Manufacturing Organizations (CDMOs) are becoming increasingly pivotal. At CPHI Milan, October 6 – 8, 2026, Grand River Aseptic Manufacturing (GRAM) will showcase its innovative capabilities, particularly in aligning manufacturing capacity and capabilities with clients’ long-term goals, at booth #8A26.

De-Risking the Path to Commercial Supply

GRAM’s approach is built on understanding a client’s long-term commercialization strategy rather than focusing only on immediate campaigns. By collaborating closely with clients, GRAM ensures forecast assumptions, launch timelines, and market growth expectations are woven into capacity planning. Evaluating forecast scenarios early allows CDMOs to proactively identify capacity constraints and implement necessary expansion plans or equipment investments. This forward-thinking strategy not only aligns current manufacturing capabilities with future demand but also mitigates risk, enabling smooth product transitions with consistent performance and giving clients the confidence they need as their products advance toward commercialization.

Risk Mitigation in Sterile Manufacturing

In sterile manufacturing, risk mitigation starts with facility design. GRAM incorporates redundancy into critical utilities such as power distribution, HVAC systems, and environmental monitoring systems. Equipment is also considered. Alternative manufacturing pathways are essential for operational resilience during maintenance events or unexpected downtime. Moreover, integrating digital manufacturing technologies and automated monitoring systems improves visibility and enables early detection of potential quality issues.

Streamlining Technology Transfer

A significant step during scale-up is technology transfer—the transition of processes that perform well in development settings to commercial volumes. This challenge is addressed through early process characterization and robust transfer protocols. Close collaboration among development, manufacturing, engineering, and quality teams ensures that processes maintain their integrity during scale-up.

Emphasizing Yield and Waste Reduction

To maximize profitability, understanding processes to reduce waste is paramount. Thorough process characterization helps manufacturers predict performance and minimize variability. Automation capabilities speed up batch release activities, significantly reducing bottlenecks and improving efficiency. In high-value biologics and advanced therapies, even minor yield improvements can lead to substantial economic benefits.

Investing in Modern Fill-Finish Technology

As demand for sterile fill-finish manufacturing rises, GRAM stands out for its contamination control, quality processes, and modern technology. By leveraging a variety of filling technologies and manufacturing platforms, GRAM supports liquid and lyophilized vial, syringe, and cartridge programs from clinical development to commercial supply using its five sterile filling lines:

  1. One groninger 10-head Syringe and Cartridge Filling Line with SKAN isolator
  2. One Bausch + Ströbel 8-head Vial Filler w/SKAN Isolator
  3. One Bausch + Ströbel 4-head Vial Filler w/SKAN Isolator and IMA LyoMax 17 Lyophilizer
  4. One Bausch + Ströbel 4-head Vial Filler w/SKAN Isolator
  5. One Bausch + Ströbel PFS and Cartridge Modular Filler w/SKAN Isolator

A Vision for the Future

For pharmaceutical innovators, choosing a CDMO involves more than available capacity. GRAM’s investments combine modern aseptic processing technology with expanded production capabilities tailored to pharma and biotech sterile manufacturing requirements. With three of its five GMP manufacturing sites built after 2018 and designed with Annex 1 compliance in mind, GRAM is equipped with advanced filling and finishing technologies and processes to support both commercial launches and the expansion of established therapies.

Conclusion

At CPHI Milan 2026, Grand River Aseptic Manufacturing is poised to demonstrate how strategic alignment, innovative technology, and proactive risk management can shape sterile fill-finish of biologics. As the industry advances, delivering high-quality sterile fill-finish services will be more essential than ever. Explore these exciting advancements and how they can benefit your pharmaceutical journey at #8A26!