Standardization In Large-Volume Subcutaneous Delivery: A Collaborative Approach

Republished with permission from Contract Pharma. The Contract Pharma source can be found here.

The shift toward large-volume drug delivery is no longer a distant trend; it is a current reality driven by a wave of innovator products exceeding 5 mL and an upcoming surge of biosimilars. To meet this demand, the industry must solve a critical paradox: the need for rigorous standardization across the primary container ecosystem versus the requirement for device flexibility. Relying on fragmented, custom solutions often leads to prohibitive costs and extended development timelines that can delay patient access to life-changing therapies.

True progress requires deep, transparent collaboration between CDMOs and device innovators to establish a unified standard for large-volume components. By aligning on these foundational elements now, stakeholders can eliminate redundant investments and streamline the path to market. Establishing these standards ensures that the next generation of on-body delivery systems remains scalable, cost-effective, and centered on the patient experience. Explore how these strategic partnerships are shaping the future of delivery.