Large-volume subcutaneous injections
Transforming healthcare with patient-centric treatment of large-volume biologics
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 are administered via intravenous (IV) or subcutaneous (SQ) routes in a hospital or doctor’s office. IV administration quickly achieves therapeutic levels in the bloodstream but is often associated with high healthcare costs, time-consuming procedures, and the need for trained medical professionals.
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.
Introducing subcutaneous injections of large-volume biologics
As biologic drugs evolve, 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 for patients to fully benefit from SQ administration.
Drug stability
The complex molecular structure of long-chain biologics increases the risk of drug interactions with container materials, potentially reducing efficacy. Over time, silicone oil migration can elevate extrusion force or injection time, proteins may aggregate due to tungsten or silicone oil, and leachables may occur. Predicting these interactions is challenging for drug developers, requiring thorough risk analyses and stability tests before regulatory approval.
Safe and easy administration
Container functionality is crucial for drug stability and easy administration, especially with on-body delivery systems, pens, autoinjectors, and infusion pumps. Precise geometry in cartridges and syringes ensures accurate dosing and reduces injection forces. High-viscosity biologics can cause pain and require more force and longer times to inject, which is challenging for manual injections. Also, automated systems may need more force, leading to larger and noisier devices, with the risk of potential damage to the primary container.
Innovative solutions for large-volume biologics
To address high-viscosity biologics and drug-container challenges, developers need high-quality containers with low extractables and leachables profiles, typically made from premium borosilicate glass or advanced polymers like COC with reduced silicone and specialized elastomers. Moreover, innovative autoinjectors, pens, on-body delivery systems and infusion pumps including the primary packaging containers such as glass syringes or cartridges are able to manage the increased force of high-viscosity injections.
At SCHOTT Pharma, we prioritize patient convenience and safety with solutions that ensure precise and user-friendly drug administration. Partnering with top device suppliers ensures a smooth container-device interface for enhanced efficacy. Additionally, our analytical services provide a comprehensive testing suite to evaluate syringe and cartridge systems under specific conditions, aiding in system selection and collecting data for drug submission dossiers.
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.
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