Child sitting on a chair smiling with on-body deliver system attached to arm.

Large-volume subcutaneous injections

Transforming healthcare with large-volume subcutaneous solutions for patient-centered treatments

Biologics are revolutionizing the treatment landscape for many serious diseases, including cancer, metabolic disorders, cardiovascular conditions, genetic disorders, and immunological diseases. With over 6,200 drugs in development, 80% of which are biologics, the future of healthcare is set for significant advancements (source: Globaldata, May 2024). However, the administration of these complex medications presents unique challenges.

Traditionally, biologics have been administered via intravenous (IV) or subcutaneous (SC) routes in a hospital or doctor’s office. IV administration quickly achieves therapeutic levels in the bloodstream but is associated with high healthcare costs, time-consuming procedures, and the need for trained medical professionals. This creates a substantial burden on patients and healthcare systems, particularly for long-term and frequent treatments. With an aging population and an increase in chronic conditions, the financial impact on healthcare resources becomes even more significant.

Subcutaneous injections offer a more patient-friendly alternative. Devices such as pens, autoinjectors, on-body devices, and infusion systems empower patients to self-administer medications for chronic conditions such as diabetes and rheumatoid arthritis at home. This approach improves patient adherence and reduces the overall treatment burden on caregivers and healthcare systems.

CHALLENGE

Are you ready for subcutaneous injections of large-volume biologics?

As technology evolves, the potential for self-administration increases, enhancing patient experience and adherence. However, subcutaneous delivery using pens, autoinjectors, on-body delivery systems, or infusion pumps faces challenges, particularly with high-viscosity or large-volume biologics, which must be addressed to fully benefit from SC administration.

Laboratory technician packing boxes of SCHOTT TOPPAC® infuse polymer syringes

Meeting tight timelines

Pharmaceutical companies are under significant pressure to meet tight clinical testing timelines and bring new drugs to market quickly. Delays caused by extended testing or long lead times can jeopardize projects, making speed essential to maximize patent lifetimes and deliver life-saving treatments to patients. However, this urgency is compounded by complex regulatory requirements and limited industry experience with filling large-volume containers.

Laboratory technician sets up analysis equipment

Navigating new challenges

Pharmaceutical companies are navigating new challenges as they adapt to emerging technologies and processes. Limited device compatibility makes second sourcing difficult, while unclear ownership creates uncertainty about who to contact for support. At the same time, large-volume injections bring high costs and risks, highlighting the need for reliable and efficient solutions in this evolving landscape.

Young child self-injects medication using an autoinjector

Ensuring patient-centered quality

Container functionality is essential for maintaining drug stability and ensuring effective administration. High-viscosity biologics present challenges by causing pain as they require more force and extended injection times, which can lead to larger, noisier devices and the risk of container damage. Additionally, the complex molecular structure of biologics increases the sensitivity to interactions with container materials, potentially affecting drug efficacy. Issues such as silicone oil migration, protein aggregation, and leachables necessitate comprehensive risk analysis and stability testing to guarantee performance and regulatory compliance.

Dominique Bauert, Head of Business Development Sterile Solutions, SCHOTT Pharma
At the heart of any injection device sits the primary packaging. It is a crucial component because it is the main point of contact between the drug and the device, yet its importance is often overlooked.
SOLUTION

Innovative primary packaging solutions for large-volume biologics

To address high-viscosity biologics and drug-container challenges, developers should use high-quality containers with low extractables and leachables (E&L) profiles. These containers are typically made from premium borosilicate glass or advanced polymers such as Cyclic Olefin Copolymer (COC) and feature modified silicone and specialized elastomers.

Innovative containment and delivery systems such as autoinjectors are essential for managing the increased force needed for high-viscosity injections. Durable primary containers such as polymer syringes, glass syringes, and cartridges minimize damage from these forces. Alternatively, on-body delivery systems (OBDS) and infusion pumps can slowly infuse larger volumes of high-viscosity biologics.

At SCHOTT Pharma, we prioritize patient convenience and safety with solutions that ensure precise and user-friendly drug administration. Our cartridges and syringes feature precise geometry to provide accurate dosing and reduce injection forces. This enables seamless integration with a variety of injection devices, including pen injectors, autoinjectors, on-body delivery systems, and infusion pumps. By partnering with leading device suppliers, we guarantee a smooth container-device interface for reliable second sourcing. Our comprehensive regulatory and analytical support ensures a smooth path to market for your drug product.
Two syriQ BioPure® 5.5 ml glass syringes
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syriQ BioPure® for autoinjectors

syriQ BioPure® 5.5 ml is the latest addition to the syriQ BioPure® platform for biologics and sensitive drugs. It leverages existing components to accelerate the time to market for large-volume drugs. It is the first large-volume glass staked-needle PFS designed for use with autoinjectors in subcutaneous injections. syriQ BioPure® 5.5 ml is compatible with the YpsoMate 5.5 autoinjector and is supplied in the standardized SCHOTT iQ® nest and tub configuration to maintain high container quality and maximize fill-and-finish efficiency.

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Two glass pharmaceutical cartridges
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cartriQ® for delivery systems and autoinjectors

cartriQ® sterile cartridges offer a stable solution for biologics in delivery systems and autoinjectors, like SHL's Maggie and Ypsomed’s YpsoDose®, which can accommodate large volumes of 5 ml or 10 ml. They feature prequalified biologic-specific rubber components and use advanced siliconization for optimal performance. With precise inner dimensions, they ensure excellent functionality and dosage accuracy. Part of the SCHOTT iQ® platform, the standardized secondary packaging maintains high container quality and maximizes fill-and-finish efficiency.

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Two SCHOTT TOPPAC® infuse syringes
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SCHOTT TOPPAC® infuse for SC and IV infusion pumps

SCHOTT TOPPAC® infuse prefillable polymer syringes offer outstanding stability and barrier properties, enhancing drug stability and shelf life. Compatible with KORU Medical’s Freedom System, they handle large volumes from 10 ml to 50 ml. They ensure low protein adsorption, stable pH, no ion or metal release, and have a cross-linked silicone layer with minimal free silicone to avoid protein agglomeration. Delivered in a standardized nest and tub, they are designed to prevent contamination and breakage during transport.

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Two female laboratory technicians examine a glass cartridge system
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Functional testing for large-volume delivery systems

SCHOTT Pharma’s functional testing services provide a comprehensive analytical testing suite to evaluate syringe and cartridge systems with drug products under specific conditions. We assist in comparing systems for data-driven selection and data collection for drug submission dossiers. Our tests help identify issues throughout the product lifecycle, from development to commercial operation.

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FILL-AND-FINISH

Biologics filling operations with ready-to-use containers

The limited patient population for biologics impacts filling operations, affecting the primary packaging in autoinjectors, wearable devices, and infusion pumps. As biologics are typically produced in smaller batches, pharmaceutical manufacturers have focused on cost-effective filling solutions. This has led to a trend in ready-to-use (RTU) containers using a standardized nest and tub format, facilitating the efficient use of filling lines and minimizing changeover time to meet evolving market demands. Additionally, RTU packaging arrives sterile at the manufacturing line, enabling fully aseptic manufacturing processes. SCHOTT Pharma has a wide network of fill-and-finish equipment manufacturers and CDMOs to enable fast filling of your drug.

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Isabelle Jeangoudoux

Isabelle Jeangoudoux

Head of Global Product Management​ Glass Syringes​

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