SCHOTT Pharma, a pioneer in drug containment solutions and delivery systems, introduces the industry’s first ready-to-use (RTU) polymer cartridge that complies with ISO dimensions. This breakthrough innovation features exceptionally tight manufacturing tolerances, offering increased design flexibility for pharmaceutical companies and device manufacturers. It facilitates enhanced device compatibility with common injection systems such as pens and simplifies drug administration – both in clinical settings and for at-home use. Building on its deep expertise in polymer syringes and glass cartridges, SCHOTT Pharma combines a proven industry track record with regulatory support, fast time-to-market capabilities, and an unwavering commitment to quality. This positions the company as a reliable and forward-looking partner for the pharmaceutical industry. “With this second polymer option in our product portfolio, we offer pharmaceutical companies unbiased material solutions tailored to their specific needs,” says Andreas Reisse, CEO of SCHOTT Pharma. SCHOTT TOPPAC® cartridge is particularly suitable for sensitive biologics, including cell and gene therapies, biosimilars, and emergency drugs. It will be presented for the first time at this year’s PDA Universe of Pre-Filled Syringes and Injection Devices Conference in Vienna, Austria, and at the CPHI tradeshow in Frankfurt am Main, Germany. It is already available as a sample for non-human testing.
As the biologics market continues to expand, fuelled by breakthroughs such as cell and gene therapies, drug developers face increasing demand for safe, patient-friendly delivery and administration solutions. These must ensure drug stability, support high-volume administration, and offer broad device compatibility. To meet these needs, SCHOTT Pharma has developed its first RTU polymer cartridge made from Cyclic Olefin Copolymer (COC), featuring a homogenous, cross-linked siliconisation layer.
The inert surface minimises protein adsorption, provides low levels of extractable and leachables, and ensures consistent break-loose and gliding forces throughout the product’s shelf life. This makes the cartridge an excellent choice for highly sensitive proteins, viscous drugs, and emergency medications. The polymer cartridge delivers functional performance comparable to glass, with added break resistance.
High-precision manufacturing for seamless integration
Produced using advanced injection moulding technology, the SCHOTT TOPPAC® cartridge offers exceptional dimensional accuracy and allows for customisation. Two key features stand out: an overfill geometry that helps reduce variability in fill volumes, thereby minimizing drug waste for high-value formulations, and tight tolerances in the cone and flange areas, which enhance adaptability to a wide range of injection devices. Through close collaboration with leading device manufacturers, SCHOTT Pharma ensures optimal compatibility for pen-based delivery systems. Moreover, X-ray sterilisation eliminates the risk of ethylene oxide (EtO) residues.
Proven expertise and scalable infrastructure
The SCHOTT TOPPAC® cartridge benefits from decades of experience and performance data gathered from the company’s established SCHOTT TOPPAC® product family. As the world’s largest manufacturer of prefillable polymer syringes made from COC, SCHOTT Pharma has supported the approval of over 80 drugs, including four blockbusters, using its polymer platform over the past 20 years.
This innovation builds on that experience and is further backed by the industry's most comprehensive cartriQ® ready-to-use glass cartridge portfolio, enabling the company to rapidly scale polymer cartridge production as demand grows.
By offering both polymer and glass options, SCHOTT Pharma provides a robust and versatile cartridge portfolio that supports a wide range of technical and commercial needs in biologics development.
The polymer cartridge is manufactured in St. Gallen, Switzerland, with the flexibility to expand production to other European sites. It is currently available in 1.5 ml, 3 ml, and 5 ml formats, with a 10 ml version in development. The cartridge is compatible with all major fill-and-finish lines, paving the way for a fast and low-risk path to market.
