Co-creation for GLP-1 RTU cartridges

Key takeaways
              GLP-1 therapies are driving demand for RTU cartridges for pens and auto-injectors
Stevanato Group and Syntegon have teamed up to develop an advanced EZ-fill® cartridge manufacturing process
Moving cartridge crimping into an isolator environment helps reduce contamination risks
The new process supports Annex 1 compliance through higher sterility assurance and less manual intervention
EZ-fill® cartridges from the new line are expected to be available in early 2027

            

Pharmaceutical manufacturers are under pressure to scale production efficiently while maintaining high quality and patient safety. Ready-to-use (RTU) containers help address this challenge. Instead of cleaning, depyrogenating, siliconizing and sterilizing components in-house, drug producers receive sterilized containers and can focus on their core process. This can reduce complexity, save space, and support more flexible production – particularly relevant for GLP-1 drugs used to treat Type 2 diabetes and obesity.

Stevanato Group, a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, is currently advancing its manufacturing process for EZ-fill^® cartridges.

“We strive to support our customers in achieving the highest possible product quality. Hence, we are constantly looking to improve our own manufacturing to match the standards of their fill-finish processes.”

Daniel Martinez, Senior Director Product Management DCS at Stevanato Group

Moving cartridge crimping into an isolator

Stevanato Group and Syntegon have been working together for many years. Syntegon has long-term experience in both fill-finish and barrier technologies, which is crucial for the current project. “In a highly regulated industry with very strict quality requirements, cooperation is essential to offer our joint customers the ideal solutions,” Daniel Martinez underlines.

While cartridge crimping is commonly performed in a restricted access barrier system (RABS), the company plans to move this process into an isolator environment. Syntegon’s isolator technology, based on the MLD platform, plays a central role here. The system includes integrated air handling, HEPA filtration, ventilation technology for positive overpressure, and bio-decontamination cycles using hydrogen peroxide. This setup helps create a controlled aseptic environment and reduces contamination risks during cartridge manufacturing. The result: with the highest possible quality, supporting pharmaceutical manufacturers in complying with Annex 1 requirements.

Discover cartridge filling solutions

Supporting Annex 1 compliance

The revised EU GMP Annex 1 places strong emphasis on contamination control strategies and reduced manual intervention in aseptic processes. By using isolator technology, the new manufacturing approach provides a high physical barrier between operators and the process zone. For pharmaceutical manufacturers, this means EZ-fill^® cartridges can support safer, more efficient fill-finish operations.

Since the cartridges are fully siliconized and crimped, pharmaceutical manufacturers can concentrate on filling and stoppering while relying on upstream preparation by the primary packaging supplier. Additional quality measures, such as clip systems to avoid glass-to-glass contact and camera-based inspection systems, help ensure consistently high cartridge quality.

Preparing for future demands

One thing is clear for Daniel Martinez: “We believe that both auto-injectors and pens will remain at the forefront of GLP-1 delivery in the foreseeable future. This potential blockbuster treatment for diabetes and obesity presents considerable opportunities for our pharma partners.” With its advanced manufacturing process and Syntegon’s scalable MLD platform, Stevanato Group is preparing to meet this demand. EZ-fill^® cartridges from the new line are expected to be available in early 2027, supporting future-proof pharmaceutical production for GLP-1 therapies and beyond.