The webinar will provide updates from the U.S. Pharmacopeia (USP) efforts to develop and implement standardized System Suitability Standards (SSS) for Extractables and Leachables (E&L) testing, addressing the lack of global regulatory guidance and variability in data quality. Initiated in 2021, the project involved extensive stakeholder engagement, laboratory studies, and a global round-robin study across 13 labs using GC-MS and LC-MS platforms. The standards aim to ensure instrument performance and data reliability through carefully designed compound mixtures. Based on feedback and study results, the mixtures were re-optimized and stability-tested, with plans for industry release in Q3 2026 and potential inclusion in USP General Chapter <1663>. The presentation also highlights ongoing efforts to develop standards for rubber oligomers and materials of construction (MOC), and updates to enhance the USP leachables General Chapter <1664> for various dosage forms, reinforcing USP’s commitment to enhancing patient safety and regulatory harmonization.

Join Samsung Biologics to explore how ExellenS™ delivers standardized equivalency and accelerated speed across our global manufacturing network. Leveraging integrated manufacturing control systems (MCS) and ≥95% standardized facility design, we achieve seamless scalability and reduced tech transfer timelines. With 100% on-time delivery maintained despite global disruptions, our unified platforms empower predictable outcomes for complex supply chains. 

Multiparticulates like pellets, beads, and minitabs offer versatile solutions to address diverse patient-centric needs across pediatrics, geriatrics, and special populations. By overcoming key challenges such as palatability, swallowability, dosing flexibility, pill burden, and dosing frequency, multiparticulate systems enable tailored drug delivery with improved compliance and therapeutic outcomes. This presentation will explore how taste masking, flexible formats, modified-release technologies, and combination designs collectively position multiparticulates as an innovative approach that combines convenience, flexibility, and patient-centric oral delivery.

Learning Objectives:

• • Identify five major patient-centric challenges addressed by multiparticulate formulations: taste masking, swallowability, dosing flexibility, pill burden, and dosing frequency.
• • Explain how multiparticulate platforms enable customized, age-appropriate, and easy-to-administer dosage forms.
• • Evaluate formulation and process strategies (e.g., coating, layering, encapsulation) that enhance palatability, modified release, and support combination therapies.
• • Review case studies demonstrating the utilization of multiparticulates in patient-centric therapies for pediatrics, geriatrics, and chronic disease management.