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PDA Parenteral Packaging

Yitian Xiao, Global Biologics Product Expert at Datwyler, examines how the rising prevalence of biologics and sensitive therapeutics is rapidly reshaping the subcutaneous drug delivery landscape — and what that means for container closure system design. While SC administration empowers patients to self-administer at home and supports the growing shift toward decentralized, patient-centric healthcare, traditional SC injections have been limited to low volumes of typically 2mL or less due to concerns over pain, tissue tolerability, and absorption kinetics. Emerging therapies — including monoclonal antibodies, anti-cancer treatments, and long-acting neurologic formulations — increasingly require higher doses that cannot be feasibly delivered within these conventional volume constraints. This presentation explores how Datwyler has extended its NeoFlex™ plunger range to support larger containers and the novel on-body injectors designed for slow, controlled delivery — expanding the feasible range of SC administration volumes without compromising safety, therapeutic efficacy, or patient compliance. Attendees will also learn how a collaborative, open approach among container closure system and device development partners enables the optimization of pre-verified platform solutions, accelerating time to market and, ultimately, patient access to these next-generation therapies. 

Prefilled syringes and cartridges travel the world — but does your packaging hold up at 30,000 feet? In this poster presentation, Mieke Nivelle, PhD, Manager Surface Development Healthcare, introduces a vacuum-based method developed to evaluate plunger movement during high-altitude transport simulations of filled syringes and cartridges. The study examines how headspace height, plunger diameter, siliconization, storage time, and simulated altitude each influence the risk of plunger displacement — and the potential sterility breach that could follow. Using an edge-of-fail approach, the team establishes maximum allowed headspace height limits across a range of NeoFlex™ and ISAF plunger configurations, providing pharmaceutical manufacturers with practical, data-driven guidance for securing container closure integrity throughout the global drug supply chain.