BD

Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parente...

Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parente...

Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parente...

Paris once again welcomes Europe’s leading trade show in pharmaceutical packaging and drug delivery innovation. Join our content team as Pharmapack 2024 opens its doors to leading experts and innovators in pharmaceutical packaging and drug delivery. 

Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parenteral drug delivery systems, including glass and plastic syringe systems, self-injection devices, safety and shielding systems that set the standard.

We will take a look at trends in the pharma pipeline for high-dose biologic subcutaneous delivery and the latest transitions from IV to SC delivery. Identify the emerging and current use cases for high-dose biologics – let’s talk about the settings, applications and delivery approaches being deployed. What are some of the challenges facing the market today for LVSC delivery and how might delivery approaches evolve? What are the technology options available and emerging to help serve the expanding design space. Where is the tipping point for LVSC delivery?

As the biologics pipeline continues to evolve toward higher concentrations and viscosities, subcutaneous delivery faces increasing challenges in usability, balancing injection force and time, and optimizing patient experience. With biologics in development reaching significantly higher viscosities (30cP+), there is growing demand for advanced delivery solutions that exceed the capabilities of today’s standard. The BD Neopak™ XtraFlow™ Glass Prefillable Syringe portfolio, featuring ultra-thin wall 8mm needles, is engineered to reduce injection time and force, enabling delivery of high-viscosity drugs. Complementing this innovation, BD applies advanced injection science, including predictive modeling, tissue response analysis, and fluid dynamics simulations, to help our pharmaceutical partners derisk their delivery strategies and optimize combination design. This Learning Lab explores how this integrated approach, uniting platform innovation with deep scientific expertise, is supporting our pharmaceutical partners in pushing the boundaries of subcutaneous delivery and unlocking new possibilities for the next generation of biologics.

Evaluating Plunger Movement and Container Closure Integrity of Combination Products Under Simulated Air Shipment Conditions

When submitting a generic drug-device combination product in the US, pharmaceutical companies must follow the FDA guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry”. As part of this guidance, a threshold analysis is performed to assess the differences between the Reference Listed Drug (RLD) and the generic drug. If “other” differences are identified, a comparative use human factors (CUHF) study may be needed to prove the non-inferiority between the two products. During this presentation, a case study will show how a device constituent developer performed a comparative analysis and formative CUHF study to help inform pharmaceutical companies’ final CUHF parameters and de-risk their combination product ANDA submission.