Overcoming Volume and Viscosity Barriers in Biologic Formulations

Key Considerations for Container Compatibility and Device Integration in Subcutaneous Drug Delivery

Abstract

The pharmaceutical and healthcare sector is evolving due to key trends: rising chronic disease rates, a shift toward home-based care, growth in biologics, and a transition from intravenous (IV) to subcutaneous (SC) drug delivery. These developments present major formulation and delivery challenges. Biologics like mAbs require higher volumes and concentrations to ensure stability and reduce dosing frequency, often leading to high viscosity. 

Traditional containers are often unsuitable for addressing these hurdles. They fail to mitigate drug compatibility risks, which can potentially impact product stability over time and patient safety. 

When selecting an appropriate container for biologic drug delivery, several critical factors must be considered to ensure both compatibility and performance. These include the target injection volume, the presence and concentration of excipients, and the seamless integration with existing delivery devices. 

In this webinar, we’ll explore key challenges and present innovative solutions to enhance drug stability, patient comfort, and device performance. 

We'll examine the features of syringe-based systems, including volume constraints and formulation risks, and introduce Stevanato Group’s Alba^® platform. Thanks to its innovative crosslinked coating, this platform is designed to ensure consistent gliding force and minimize drug-container interactions. 

We’ll also highlight how needle parameters must be selected to guarantee the required efficacy and safety while supporting patient comfort and therapy adherence, and how an optimized needle design, featuring a shorter length and an enlarged internal diameter, can result in lower injection forces and easier administration. 

Finally, we will address scenarios where formulations exceed the volume limits of syringes or are sensitive to evaporation and precipitation. In such cases, cartridge-based systems offer an ideal alternative. With our extensive portfolio of Nexa^® EZ-fill^® (RTU) cartridge systems, featuring volumes from 1.5 to 20 mL, we offer versatile injection options tailored to diverse self-administration requirements in homecare environments, including pairing cartridges with on-body delivery systems.

Challenges this content will address

• Ensuring drug safety and stability when formulations are aggressive.
• Selecting appropriate containers and devices to deal with high-viscous drugs.
• Dealing with high-volume injections.

Learning Objectives

• Alba^® syringe coating addresses challenges linked with high-concentration formulations.
• Specific needle solutions for injecting high-viscous drugs were developed to enhance patient comfort.
• Cartridges are a valid alternative to syringes, not only for large volume applications but also when formulation is sensitive to evaporation or precipitation.

Speakers