Opening Remarks

Study reveals glass PFS can be stored at -20°C and -40°C without risk on PFS key product functions, establishing pathway to further assess the stability and performance of drug combination products with PFS in deep cold conditions.  

In this interview published in June 2020 in a special COVID-19 issue of Pharma’Post, Marie-Liesse Le Corfec, Head of Global Portfolio Marketing, presents the variety of means and capabilities deployed by BD to support Covid-19 drug and vaccine developers, help accelerate time-to-market and support global health.

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World’s largest syringe maker gears up for increased demand across all product classes amid expected COVID-19 vaccine roll out

In this webinar, originally broadcast as a part of Pharmapack Europe, Eve-Marie Vaccaro, Global Sales & Operation Planner, and Edgar Bauer, Global Key Account Manager Bausch+Ströbel from BD Medical - Pharmaceutical Systems discuss how VHP sterilization is a viable alternative for ensuring improved patient safety by providing a sterile product application for drug delivery devices, such as pre-filled syringes with temperature or radiation sensitive drug products, that are too sensitive for conventional methods of sterilization. Material selections, device design, properties of the pre-filled syringe, and secondary packaging decisions (shape, materials) play an important role in ensuring the sterilization process is successful. The major things to avoid are known in the industry, but there are more opportunities for proactively preparing for this in advance, during the design phase, when making considerations for the intended sterilization method - for example - thinking about applying the IPCD (internal process challenge device and EPCD (external process challenge device) in good time beforehand. These are key considerations when aiming at short lead-time product-to-market strategy - from sterilization perspective. This presentation looks at these from this viewpoint.

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.

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.

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.

Sterile pharmaceutical production is expected to grow by over 50% in the next seven years, driven by new demand for recombinant antibodies and small molecules. Consequently, the fill/finish stage in pharmaceutical manufacturing is becoming a bottleneck in the pharmaceutical production . Health authorities and regulators are also demanding enhanced traceability during the manufacture of parenteral medicines as the most common processes and technologies in place are reaching their limitations . Addressing this challenge means boosting Overall Equipment Efficiency (OEE) while meeting rising regulatory demands. This presentation explores an innovative solution to address this dual challenge: Container-level traceability (CUID). This pioneering approach utilizes RFID (Radio Frequency Identification) to ensure accountability for each container in the fill-finish processes, down to the individual unit. In the short term, CUID can mitigate exposure to mix-up, improve OEE through automated reconciliation, and cut waste with unit-by-unit segregation. Beyond this, CUID has the potential to eliminate data silos and bridge the gap between each manufacturing process step. Manufacturers can harness advanced data analytics to unveil hidden patterns, identify process inefficiencies, and detect trends and anomalies that were previously unnoticed. Becton Dickinson selected RFID technology for pre-fillable syringes based on the relatively low impact on existing manufacturing lines and the high potential for future applications. In collaboration with Avery Dennison Smartrac, a leading provider of RFID inlay solutions, BD has conducted a proof of concept and will demonstrate the feasibility of the solution through a video of BD’s RFID Demonstration Lab and a live demo.

Numerous drug technologies are advancing into pre-clinical and early clinical phases to enable new therapies with improved health outcomes. Those new technologies carry potential challenges pertaining to their compatibility with the container materials and with environmental conditions such as temperature or exposure to gases. One historically common degradation pathway of pharmaceuticals is oxidation. More and more prefillable plastic syringes are being developed as they present advantages over glass syringes on parameters such as lower inorganic extractables and a higher resistance to breakage. Plastic syringes are mostly made of COP and COC barrel materials, materials which are much more permeable to oxygen than glass. A highly oxygen-permeable container results in a faster oxygen ingress, leading to faster oxidation. For oxygen-sensitive drug formulations, this can lead to a decrease in the drug shelf life. Decreased shelf life may be mitigated by increasing the concentration of antioxidants or by adding an oxygen scavenger in the secondary packaging, which can pose other constraints. Therefore, there is a need to monitor and quantify the oxygen ingress within prefillable syringes to derisk pharma combination product development. This study, conducted on several prefillable syringe configurations, will highlight the influence of components on oxygen permeation and measure the syringe protection performance against oxygen ingress at different storage temperatures.

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

Transitioning drugs from IV to subcutaneous (SC) delivery brings new requirements and impacts program considerations for combination product development. In this session, we identify trade-offs that pharma weighs to de-risk combination product development programs involving large volume subcutaneous (LVSC) delivery. Key issues can include: Understanding the patient experience throughout the injection process with large volume subcutaneous delivery Reducing risk of user variability to gain market confidence in successfully delivering LVSC formulations Leveraging partner capabilities, insights, and data to inform combination product trade-offs and program risks Manufacturability of the combination product including the delivery system and integration into the pharmaceutical operations network Exploring the value of drug delivery technology used consistently from clinical development into commercial use Examples of how these issues can impact a combination product development program may be explored.

Human Factors Engineering (HFE) process participates in the product development for a safe and effective use by the end-user population. HFE data are under agencies' scrutiny as part of the design control of a drug - device combination product. Timely planning can be challenging during combination product development. Session outline: HFE definition and overview of the regulatory landscape Presentation of formative and summative studies process Benefits and planning of HFE activities during combination product development Benefit: Beyond the definition of Human Factors Engineering, understanding how studies­ related activities impact the final product design and how to plan for timely data generation during combination product development.

As the number of patients managing chronic diseases continues to increase, self-injection solutions play an important role in enabling the shift towards home care. Identification of potential use errors is a critical task during device development to support patient acceptance and usability. The design of these solutions can help overcome some of the usability challenges associated with self-injection, such as injection time limits and risk of premature device removal. As biologic dose volume and viscosity increases, meeting injection time requirements and usability considerations with autoinjectors can be increasingly challenging. During this session, we will discuss device design elements that can impact the hold time of autoinjectors and the resulting usability considerations, such as the gap between second click and actual end of dose. Premature device removal is one example of usability errors that can result from the second click occurring before actual end of dose. Design alternatives to avoid risk of premature device removal during self-administration will be explored including that of the BD Physioject™ Disposable Autoinjector and the BD Libertas™ Wearable Injector.

Sub-optimal adherence and persistence to treatment continue to be significant challenges for both on-market drugs and investigational products in clinical development. This is especially true for self-administered medications for chronic disease patients, hence driving the need for improved treatment intake monitoring technologies. To answer this need, BD and Biocorp have joined forces to develop a connected version of the BD UltraSafe Plus™ Passive Needle Guard that facilitates the traceability of injections. During this workshop, the speakers will welcome you for an interactive presentation featuring the following topics: • Unmet needs in clinical & real-life settings: the challenge of treatment adherence • The solution: overview of the connected BD UltraSafe Plus™ Passive Needle Guard, technical details and value proposition for different stakeholders • Interactive demo session • Use cases: how the connected BD UltraSafe Plus™ Passive Needle Guard can fit into clinical and real-life practices