10.03.26 -- Drug Delivery Leader Best Of September

In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).

In this episode of In Combination, representatives from the Immunogenicity subteam within industry association The  Subcutaneous Drug Development & Delivery Consortium join host Tom von Gunden to discuss the role and impact of immunogenicity in biotherapeutics product development for sub-Q delivery. Members of the subteam describe the group’s focuses on degrees of desired or acceptable immunogenic response, as well as on industry harmonization of assays employed in preclinical and clinical modeling. 

On a return videocast appearance, CEO Aaron Mann of autoinjector provider Windgap Medical joins Supplier Horizons host Tom von Gunden to discuss product development decision points around delivering complex molecules via autoinjectors. These cross-functional considerations for drug teams and device teams include high viscosity formulations, device capabilities, product stability, patient safety, and human factors.

Classifying eye drops as combination products complicates approval. Learn how identifying the primary mode of action early and aligning dual quality frameworks prevents costly launch delays.

A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.

Explore how adaptable technologies and strategic partnerships help navigate Annex 1 compliance and technical hurdles to ensure the successful delivery of complex drug products.