Redefining healthcare: the power of large-volume sterile cartridges

The rise of large-volume SC injections

The growing preference for SC injections over IV infusion is driving demand for specialized drug containment and delivery systems that support volumes greater than 3 ml. Many biologics need to be injected in higher doses, with their complexity and sensitivity requiring innovative containers to ensure they remain stable and effective until the point of use.

Until recently, the choice of containers for self-administration devices handling volumes above 3 ml was limited. While conventional prefilled syringe (PFS) autoinjectors were available up to 2.25 ml, cartridge-based autoinjectors were available up to 3 ml. For higher volumes, on-body injectors are an established next step, offering controlled delivery over extended periods and the potential for smart connectivity. However, these systems can be more complex and costly and may not always align with patient preferences for simplicity and discretion.

For the more familiar and convenient self-administration of up to 5 ml of drug formulation, pen or autoinjectors offer a promising alternative for patients who require larger doses but do not need the prolonged infusion capabilities of on-body systems or a highly time-critical injection. However, both approaches have their place in the treatment landscape depending on the therapeutic context and patient needs.

Challenges for large-volume drug formulations

Used to treat a wide range of life-threatening conditions, including cancer, cardiovascular conditions, genetic disorders, and immunological diseases, biologics are a critical area of global healthcare. However, there are several challenges when developing for and selecting large-volume containers for biologics. These include:

• High sensitivity: Since biologics can denature or degrade when exposed to environmental influences such as light, heat, or oxygen, the materials used in their containers need to provide an effective barrier.
• Minimal drug-container interaction: The container material must be highly stable, with a low extractables and leachables (E&L) profile to prevent any interaction with the drug.
• Precise dosage accuracy: Patients must receive exact amounts of a drug every time it’s administered, so the packaging must provide extremely accurate dimensions and dosage.
• Viscosity: Drug viscosity is an essential aspect of both the fill-and-finish and injection stages of drug administration and can affect dosage. As drug concentration increases, so does its viscosity, complicating dosage accuracy.
• Free silicone: Adding silicone oil to the inner surface of a container reduces plunger friction but can result in contamination of the drug from free silicon particles.
• Injection frequency: Patients tend to prefer less frequent injections of a medication, which leads to an increase in drug dose per injection.

However, recent advances in glass containers and autoinjectors have addressed these challenges, resulting in a range of products ideal for large-volume SC injections.

Introducing cartriQ® Large Volume: SCHOTT Pharma’s sterile large-volume cartridges

The priority for any pharmaceutical large-volume container is a low E&L profile to minimize drug-container interaction and avoid pH shift of the drug formulation. Therefore, SCHOTT Pharma uses FIOLAX® CHR glass for all its cartriQ® Large Volume cartridges. This Type I Borosilicate Glass offers high chemical and mechanical stability, resulting in low leachables and low risk of delamination. This is particularly relevant during the storage and transport stages of a drug container’s journey, when pH shift and E&L concentration are crucial to control.

The presence of free silicone particles is another critical concern as they can interact with protein molecules and compromise stability by promoting protein aggregation. Silicone oil is necessary to aid plunger movement in cartridges and syringes. However, since there is a risk that the silicone particles will detach from the glass surface and contaminate the drug, SCHOTT Pharma uses a ‘baked-on’ process for its ready-to-use (RTU) cartridges to form covalent bonds between the glass and the silicone. This significantly reduces the risk of free silicone as this type of bond is approximately 20 times stronger than that formed by the sprayed-on process.

SCHOTT Pharma recognizes the specific needs of biologic innovators in the fill-and-finish process and addresses them by offering 5 ml cartridges in an RTU format. Part of the SCHOTT iQ® platform, cartriQ® Large Volume RTU cartridges are available in a standardized nest and tub configuration. This product undergoes stringent in-house steam sterilization to maintain a high level of sterility to reduce the number of processing steps and improve the efficiency of fill-and-finish.

Seamless integration with SHL Medical’s Maggie 5.0 ml

Ensuring device compatibility is key to safe and reliable drug administration. Manufacturing every component with high dimensional accuracy guarantees a perfect fit between the large-volume container and the autoinjector. This high precision enhances performance and prevents issues such as misalignment, leakage, or malfunction.

In addition to dimensional precision, consistent break-loose and gliding forces are essential for a smooth and predictable injection experience. These forces determine how easily the plunger starts and continues to move within the cartridge, directly impacting patient comfort and dosage accuracy. SCHOTT Pharma’s advanced manufacturing and quality control processes ensure that each cartridge delivers reliable performance, supporting both safety and user confidence. To ensure compatibility and ease of use, SCHOTT Pharma co-developed the cartriQ® 5 ml cartridge with SHL Medical to ensure compatibility with the Maggie® 5.0 ml autoinjector to create a complete, patient-friendly self-injection system to redefine healthcare.

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As the pharmaceutical world moves away from expensive, inefficient IV infusion and towards self-administered subcutaneous injection, the requirement for large-volume containers will increase. With its cartriQ® Large Volume cartridges, plus its deep well of knowledge and expertise, SCHOTT Pharma is driving this movement forward to boost the efficiency of healthcare systems and the comfort of patients worldwide in order to redefine healthcare.