Newsletter | June 2, 2026

06.02.26 -- Navigating Combination Product Development For Novel Biologics

 

Device Design To Address Usability And Mitigate Use-Related Risks

 

Increasing prevalence of chronic disease and a shift toward patient centric care are accelerating the move from clinic based intravenous delivery to large volume subcutaneous administration. Wearable injectors developed to minimize complexity for patients and caregivers must balance formulation needs, user capabilities, and environmental factors, making risk management and human factors methodologies essential throughout development.

 

De-Risking A Novel Valve Component For Use With Standard Syringe Systems

The rise of combination therapies has increased interest in delivering two liquid drugs together without mixing them before use. While many existing dual injection solutions require specialized containers or device redesigns, a novel valve has been developed to enable dual-chamber functionality within standard syringe and autoinjector systems.

 

A Smooth Transition To USP <382> With Established Expertise

A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety.

 

SOLUTIONS

BD Libertas Wearable Injector

BD Libertas™ Wearable Injector is designed to deliver subcutaneous injections of large volume (2-5 mL or 5-10 mL) and/or high viscosity (up to 50 cP) fixed dose biologics for the non-acute setting. Explore the patient experience offered by this advanced delivery system.