KEY TOPICS COVERED
The formulation science enabling large-volume SC delivery
Delivering high-dose or high-viscosity biologics subcutaneously requires formulation innovation alongside device engineering. Halozyme's ENHANZE hyaluronidase platform and Elektrofi's Hypercon concentrated microparticle suspension technology are among the enabling approaches examined in this report, alongside advances in drug container materials — including cyclic olefin polymers (COP/COC) and ultra-thin-wall needle design — that together make large-volume SC administration clinically and practically viable.
Pipeline analysis: which biologics are large-volume SC candidates
The report provides a pipeline analysis of the large-volume SC landscape, identifying the therapeutic areas and molecule types most likely to drive adoption — with oncology, autoimmune, and cardiovascular indications representing the largest share of mAb candidates currently in development that could qualify for SC conversion.
Elastomeric component requirements for large-volume applications
Large-volume auto-injectors and wearable devices place unique demands on elastomeric plunger components. Complete fluoropolymer coating is critical to prevent rubber shedding, avoid swelling in oily suspension formulations, eliminate silicone dependency, and maintain container closure integrity across transport and extreme temperature conditions in 5–20mL formats. Consistent glide force across larger formats and a simplified extractables and leachables profile — achieved when the same contact material is used for both plunger and combiseal — are equally critical considerations.
NeoFlex™ plunger platform for large-volume delivery
Datwyler's expanded NeoFlex™ plunger platform is engineered for prefilled syringes and pharmaceutical cartridges up to 20mL, manufactured in globally harmonized FirstLine® facilities, and available in steam- or gamma-sterilized ready-to-use formats. The non-fluorosurfactant fluoropolymer coating is designed to meet the biological cleanliness, fill/finish integration, and extractables and leachables profile requirements of next-generation large-volume injectable drug delivery systems.
WHO THIS REPORT IS FOR
This report is designed for formulation scientists, packaging engineers, drug delivery device teams, regulatory affairs professionals, and business development leads evaluating primary packaging component solutions for large-volume subcutaneous biologics in auto-injector and wearable on-body delivery platforms.
