Newsletter | June 18, 2021

06.18.21 -- Risk Management In Biologics Combination Product Development

 
Identifying Enhanced Needle Solutions And Integrated System Solutions To Serve The Chronic Disease Market
 

Demand for self-injection devices is rising, fueled by the prevalence of chronic diseases, biologics as a dominant therapeutic modality, and the increased demand for home healthcare. Needle innovations support the delivery of drugs with greater volumes and viscosities, enhancing end-user experience.

How Shorter Needles With Thinner Walls Are Set To Improve The Injection Experience In Chronic Care
 
This series of frequently asked questions covers the research and design mindset applied to the development of the BD Neopak™ XtraFlow™ solution and how the anticipated clinical benefits of 8 mm needles will support their broad adoption over time for subcutaneous drug delivery, particularly for use in chronic care settings.
Addressing The Evolving Needs Of Variable Drug Delivery Regimens
 

Explore a wearable solution designed to enable new delivery formats in alternate settings with customization to support adjustments and variations in treatment regimens. This article discusses the BD Evolve™ On-Body Injector and describes how the device is specifically designed to meet patient requirements and address the rapidly evolving needs of the pharma industry.

Enabling Biologic Drug Delivery Of Volumes Beyond 1 mL
 

As the biological drug design space evolves toward formulations with larger dose volume and higher viscosity, delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability.

Analytical Services: Risk Management In PFS Components Selection For Sensitive Biological Drug Formulations
 

Choosing the right containers and materials is critical but also difficult, and no methodology is available to quickly assess the risk of drug/device interaction. Here are two risk-based test methodologies to select the optimum closure materials and the correct syringe silicone level at the early phase of drug development to improve the time-to-market predictability.

Solutions