Large volume drug delivery

Where are all the On Body Delivery Devices? On Body Large Volume Injectors (LVI) have been discussed and demonstrated for over ten years, but very few of these devices have reached the hands of patients. Two of CDPs combination product experts will outline the barriers that these products have faced in coming to market and the competition that large volume auto-injectors and ambulatory infusion pumps present. The presentation will include commentary on the relevant drug product pipelines, the regulatory pathway, relevant standards and future drivers for successful LVI development.

As the landscape, development, and introduction of large-volume delivery systems continue to grow, the implementation of these devices in the Pharma ecosystem creates unique challenges for pharmaceutical companies. From the selection of drug containment materials and enclosures to device assembly needs to final packaging, the ecosystem and implementation of these devices must be carefully considered. In this quick discussion, we will review some of the ecosystem considerations below.

• Evolving landscape vs uniformity

• Device complexity and options, User Filled, User Assembled, Prefill-Preassembled

• Drug containment choices and second source de-risking

• Post fill device assembly, what complexity does this introduce and do the device companies provide turn key solutions.

• Device packaging and distribution options.

• Lifecyle management especially related to electronics/connected systems

• Sustainability opportunities and disposability

The healthcare landscape is experiencing a significant shift as traditional hospital-based care transitions to the home where feasible, enabled by innovative technologies supporting remote care, monitoring, and patient engagement. This talk aims to underscore the importance of preparing for this evolving era of healthcare, and how to ensure new medical device designs are suitable for use at home.


Key discussion points include:

• Current adoption levels, case studies, and future trends surrounding "Hospital at Home" or "Virtual Wards" in the UK/EU.

• Key considerations and challenges in developing or adapting technology for home-based care, such as user-friendly interfaces and interoperability.

• The potential impact of technology designed for home use on patient outcomes, cost savings, and overall experience, exemplified by a case study on new infusion pumps.

Product/patient safety is paramount, so how to balance the selection of packaging materials and systems with sustainability in mind? 

More sustainable solutions are coming online in different forms and need to be scaled into the market.

Challenges on the innovation side focus on the validation of important to have the integration between validation and monitoring to give comfort to industry to embrace flexibility and sustainability.

What low impact solutions can work for the pharma industry?

In an ideal world, a one size fits all would be found, but the reality is that shipping lane profiles and product requirements means that this is unlikely to be the case.

De-risking combination product development with a robust ISO 10993-1 (2018) testing strategy to support biocompatibility and minimize development timelines

Combination product development requires biocompatibility testing, as per ISO 10993-1 (2018) guidelines, which can represent a significant portion of development timelines. A strong strategic approach is imperative to meeting these requirements for biological and chemical evaluation. This presentation outlines the approach BD Pharmaceutical Systems takes when designing and implementing biocompatibility testing to meet ISO 10993-1 (2018) and regulatory requirements for combination products. Based on combination product categorization, this will include biological evaluation using in vitro and in vivo techniques, and chemical analyses to detect potential extractables. In addition, Materials of Concern declared by suppliers, as well as extractables that are detected analytically, are subjected to toxicological risk assessment as a means to de-risk the combination product. The speaker will also highlight how biocompatibility testing can help de-risk combination product development timelines for combination products by leveraging BD Pharmaceutical Systems internally generated statistics from previous regulatory body requests and resolution timelines, when supporting pharmaceutical partners’ regulatory submissions. As part of its commitment to communication, BD provides customers with documentation throughout combination product development, including an ISO 10993 statement to support combination product biocompatibility results and a Materials of Concern statement for each product design configuration.

Today’s medicine and therapeutics encompass fairly complex formulations. The device design needs to not only incorporate the challenging needs of the formulation but also address patient optimized administration and deliver consistent results. The success of the clinical outcome is dependent on the delivery optimization in these situations and thus the importance of methodologies to be able to monitor delivery and evaluate Pharmacokinetics (PK) modeling. The presentation will highlight novel methodologies developed to explore drug characterization, drug delivery optimization, and autoinjector simulator to assess pharmacokinetics / pharmacodynamics towards early evaluation and consistent results. The methodology can be used for novel therapies and unmet needs in various indications including the areas of high dose, large volume and high viscosity applications. Some case studies will be highlighted with the methodology. 


Topics include aspects of:

• Development process for Drug Delivery  

• Delivery Evaluation – Drug, Site, PK-PD modeling

• Path to Device – Injection Parameters Optimization

• Integrated Development Cycle

This session will bring together industry experts to discuss the opportunities and challenges that large-volume delivery devices have moving forward. Balancing technical and regulatory demands with ever-increasing pressures on cost-effective and sustainable solutions needs continued consideration. These topics will be discussed along with how to meet patient and healthcare expectations.