8 mm needle - Improving subcutaneous chronic drug delivery

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.  

Discover BD SCF™ PremiumCoat™ 1 mlL Plunger Stopper designed to serve the evolving needs of pharmaceutical organizations in the development of combination products for chronic diseases.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, Intevia, Neopak, SCF, UltraSafe Plus, Visioguard and XSi are trademarks of Becton, Dickinson and Company or its affiliates.  All other trademarks are the property of their respective owners. © 2021 BD. All rights reserved.

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

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.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

New solution supports injection of different viscosities and volumes without the need for system customization.

Discover a comprehensive set of services and solutions designed to mitigate the risks associated with combination product development to help you achieve your goals. These services and solutions help you from development all the way through to launch, including container selection, combination product expertise and testing, regulatory and technical documentation support, analytical testing, world class lab capabilities, ongoing consultation, and more.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

Learn about BD’s answer to the many challenges faced by pharmaceutical companies having new combination products to launch: our BD PartnerPath™️ program created for customers who value speed to market.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and PartnerPath are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Discover how BD can accompany a development team working on drugs or vaccines against COVID-19, thanks to the specific expertise of its different businesses.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

Discover BD offering to address the challenges of IV drug delivery and find the right primary container for your injectable in hospital care settings: BD Hylok™️ Glass Prefillable Syringe for IV injected drugs or BD Sterifill Advance™️ Polymer Prefillable Syringe!

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, Hylok and Sterifill Advance are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Learn about 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.

Discover why hundreds of pharmaceutical and biotechnology companies place their confidence in our high performing BD products and services...

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

Discover why hundreds of pharmaceutical and biotechnology companies place their confidence in our high performing BD products and services...

https://drugdeliverysystems.bd.com/contact-us

At BD, we have built our services and capabilities around a deep understanding of the drug development process and the key objectives at each stage. Knowledgeable and responsible, our team offers the many capabilities you need beyond taking your product to market. Each of our services is delivered intentionally and carefully to directly result in significant benefits for your product and company. 

Discover why hundreds of pharmaceutical and biotechnology companies place their confidence in our high performing BD products and services...

https://drugdeliverysystems.bd.com/contact-us

Discover our capabilities and services, and partner with us to:Save time by leveraging our tried and tested expertise and methods Save money by eliminating the need to invest in costly machinery and other resources Gain confidence by working with an organization that has successfully helped launch hundreds of drug products  Free-up valuable internal resources that may be deployed to other critical activities.For more information, contact TechnicalServices_BD[email protected] or https://drugdeliverysystems.bd.com/contact-us

Our prefillable vaccine syringes provide multiple routes of administration options while helping enhance vaccination outcomes. 

BD Hypak™ for Vaccines Glass Prefillable Syringe is our reliable glass prefillable syringe system specifically optimized for vaccinations. BD Hypak™ for Vaccines addresses customer needs of better processability of your syringe during filling and packaging operations.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Hypak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

BD Hylok™ Glass Prefillable Syringe for IV Injection is a new luer syringe for the administration of IV drugs. It offers customers the advantages of glass containers (e. g., medication stability) with a robust luer connection. BD Hylok™ is a ready-to-use glass solution, compatible with main IV connectors. Discover how  BD Hylok™  can support your prefilled syringe “First-Mover” strategy.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Hypak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

BD Neopak™ Glass Prefillable Syringe platform is built on years of BD’s unmatched experience partnering with leading biopharmaceutical companies to support drug development and launch. BD Neopak™ is conceived with a solution-finding mindset, allowing to tangibly meet your current and future needs for biotech drugs.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Neopak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

Give tomorrow’s most demanding biotech drugs the strength of BD Neopak™ Prefillable Syringe technology!

BD Neopak™ Glass Prefillable Syringe platform is built on years of BD’s unmatched experience partnering with leading biopharmaceutical companies to support drug development and launch. BD Neopak™ is conceived with a solution-finding mindset, allowing to tangibly meet your current and future needs for biotech drugs.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Neopak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

Change to the reliability of BD Neopak™ platform to accompany your brand strategy!

BD Neopak™ Glass Prefillable Syringe platform is built on years of BD’s unmatched experience partnering with leading biopharmaceutical companies to support drug development and launch. BD Neopak™ is conceived with a solution-finding mindset, allowing to tangibly meet your current and future needs for biotech drugs.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Neopak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved

When time to market is critical, invest in the reliability of BD Neopak™ Glass Prefillable Syringe For Biotech!

BD Neopak™ Glass Pre-fillable Syringe platform is built on years of BD’s unmatched experience partnering with leading biopharmaceutical companies to support drug development and launch. BD NeopakTM is conceived with a solution-finding mindset, allowing to tangibly meet your current and future needs for biotech drugs.

https://drugdeliverysystems.bd.com/contact-us


BD, the BD Logo and BD Neopak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

Concerned about silicone?

Discover BD Neopak™ XSi™ Glass Prefillable Syringe with immobilized Silicone Coating to help you address silicone-related concerns!

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, BD Neopak and XSi are trademarks of Becton, Dickinson...

Grounded on decades of BD Hypak™ experience, BD Hypak™ for Biotech has been developed to address the key compatibility challenges for biotech drugs and chronic treatments.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Hypak are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

Discover BD Vystra™ Disposable Pen, an intuitive, high-quality and customizable pen injector designed to support therapies that require frequent, low-volume injections or variable dosing.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Vystra are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

Extending its patient-centric BD Intevia™️ Disposable Autoinjector platform, BD builds on past successes while meeting the requirements of new, highly viscous, high-volume biologics for chronic diseases.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, Intevia, Physioject, Neopak and XtraFlow are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Interview of Marie-Liesse Le Corfec, Head of Global Portfolio Marketing at BD Medical - Pharmaceutical Systems, a leader in injectable drug delivery devices that is also in charge of the operational Task Force for coordinating the response and strategy with the pharmaceutical industry in the context of the health crisis.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

BD provides unparalleled parenteral drug delivery systems for a variety of therapeutic areas and settings, including glass & plastic syringes, advanced drug delivery solutions, safety & shielding systems that set the standard. Discover why hundreds of pharmaceutical and biotech companies place their confidence in BD high performing products and services.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

From drug discovery, through manufacturing and quality controls, packaging and storage to preparation and administration, BD MDS delivers reliable and innovative solutions. Discover our offering for the industry!   

Contact: BD Medication Delivery Solutions (Europe) - Route De Crassier, 17 - 1262 Eysins, Vaud - Switzerland - T: +41 21 556 30 00

BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company © 2020 BD. All rights reserved

Discover BD Eclipse™, designed and manufactured with nurses and patients in mind! BD Eclipse™ needle is easy to use with minimal training, and supports streamlined and cost effective compliance for every practitioner, every day. BD Eclipse™ family of needles is a proven technology as it meets testing requirements for internationally recognized ISO 23908 standard for sharps injury protection with hypodermic injection needles. 

Contact: BD Medication Delivery Solutions (Europe) - Route De Crassier, 17 - 1262 Eysins, Vaud - Switzerland - T: +41 21 556 30 00

BD, the BD Logo and BD Eclipse are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved

BD has developed an extensive line of safety-engineered devices, becoming a global leader in the field of healthcare workers safety. Discover our innovative portfolio of safety products protecting against needle stick injuries.

Contact: BD Medication Delivery Solutions (Europe) - Route De Crassier, 17 - 1262 Eysins, Vaud - Switzerland - T: +41 21 556 30 00

BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company © 2020 BD. All rights reserved

BD has plans to invest approximately $1.2 billion over a 4-year period. The investment will fund capacity expansion, new product innovations, manufacturing technology enhancements and business continuity improvements across its existing network, all designed to maximize supply and reduce risks for pharmaceutical companies that rely on ready-to-fill syringes for their injectable drugs - including complex biologics, vaccines and small molecules -. A new manufacturing facility in Europe is expected to be operational by the end of 2023.

More information available in our datasheet.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

"The crisis was a pilot phase during which we learned more about the strength of our systems" 
Interview given by Marie-Liesse Le Corfec, Marketing Director of the BD Medical - Pharmaceutical Systems' portfolio, who leads an internal Task Force in order to coordinate the response and strategy targeting the pharmaceutical industry during the health crisis

While traditional vaccine formulations are commonly stored up to about 2°C-8°C, new vaccine formulations – including those for mRNA – require much colder storage for over a long period of time to ensure drug-product shelf-life and potency. Such low temperatures can induce changes in container dimensions, phase transition - liquid to solid and vice versa - and thermal shock. This could compromise the functional performance of the delivery system and Container Closure Integrity (CCI). BD began its investigation on the impact of deep cold storage on glass PFS as soon as information regarding the deep cold storage requirement for mRNA COVID-19 vaccines became available in 2020.

BD study reveals that 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.

Discover more information in our press release...

The development of new parenteral biologics with high-volume, high-viscosity formulations (> 1 mL, >15 cP) is triggering the need for devices that can deliver these therapies with the ease, safety, and low injection time required for self-injection. As these formulations come to market, pharmaceutical and biotech companies must make critical device choices from an array of largely unproven options. The attachment discusses how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.  

Discover the article published in Drug Development & Delivery in October 2021 (Vol 21 No 7)...

In this article, Sam Eubanks, Vice-President of Software Development, and Hervé Soukiassian, Associate Director, R&D Project Management, both of BD Medical -  Pharmaceutical Systems, discuss the BD traceability solution. This concept under development aims to deliver traceability at the unique container level from manufacture to the point of care.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

New clinical trial data demonstrates the performance of BD Libertas™ Wearable Injector. A detailed analysis of the BD independently sponsored and conducted study has been published in Clinical and Translational Science (5 Dec 2020).

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Libertas are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Sophie Trémeau, Regulatory Affairs Specialist, Maxime Nicolas, R&D Engineer, and Myriam Leszczynski, R&D Project Manager, all of BD Medical – Pharmaceutical Systems, discuss BD Hylok™, a prefillable glass syringe for intravenous applications, including the rigorous testing BD Hylok™ has undergone and the regulatory support BD is able to provide to its pharmaceutical partners.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Hylok are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Temitope Sodunke, PhD, Strategic Innovation Leader (On Drug Delivery - February 2020)

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Evolve are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Press release - February 11, 2020

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Libertas are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Beth DiLauri, Director, Strategic Marketing, Advanced Drug Delivery Solutions (On Drug Delivery - September 2019)

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, Neopak and Libertas are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Alice Maden, Associate Director, Regulatory Affairs & Lionel Maritan, Associate Director, Research & Development (On Drug Delivery - February 2019)

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, Physioject, Intevia, Neopak and Libertas are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Aurélie Pager, Clinical & Human Factors Program Leader - Brigitte Duinat, Senior Engineer - Barbara Alves, Regulatory Affairs Specialist (On Drug Delivery - May 2020)

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo, Neopak and XtraFlow are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Sagar Bejalwar, Global Marketing Manager (On Drug Delivery - February 2019)

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Hylok are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Cécile Halté, Senior Program Manager, Acute Care Segment (On Drug Delivery - August 2019)

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Sterifill Advance are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved. 

Discover a comprehensive set of services and solutions designed to mitigate the risks associated with combination product development to help you achieve your goals. These services and solutions help you from development all the way through to launch, including container selection, combination product expertise and testing, regulatory and technical documentation support, analytical testing, world class lab capabilities, ongoing consultation, and more.

BD Libertas™ Wearable Injector with Peel, Stick & Click™ feature is designed as a prefilled and preassembled solution to deliver 2 – 5 mL or 5 – 10 mL of viscous biologics into the subcutaneous tissue, at home or in clinical settings. Discover its main features and benefits!
                                                                                                                     
https://drugdeliverysystems.bd.com/contact-us                                                                                                     
BD, the BD Logo and BD Libertas are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved.

Fabien Dubuc, Global Business Director, Combination Product Solutions and Services at BD, introduces a comprehensive set of services and solutions designed to mitigate the risks associated with combination product development to help you achieve your goals. These services and solutions help you from development all the way through to launch, including container selection, combination product expertise and testing, regulatory and technical documentation support, analytical testing, world class lab capabilities, ongoing consultation, and more.

https://drugdeliverysystems.bd.com/contact-us

BD and the BD Logo are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

Launching a combination product can be difficult and often comes with many challenges which can lead to development and launch delays. These delays equate to increased costs which can decrease the viability of market launches. The BD PartnerPath™ program was created for customers with new combination products in development, who value speed to market. It aims to help customers anticipate obstacles, mitigate risks and solve operational challenges in the early stages of drug development.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Partnerpath are trademarks of Becton, Dickinson and Company  or its affiliates © 2021 BD. All rights reserved.

Chronic diseases are on the rise worldwide. As a result, the pharma drug pipeline is rapidly changing, raising new challenges driven by more sensitive biologics, the need for home care self-injection solutions, and increasingly stringent quality and regulatory requirements. Our mission at BD Medical - Pharmaceutical Systems is to be your preferred strategic partner for high quality, innovative drug delivery solutions and services. We support the success of your combination products to make a real difference in patients’ lives. Drawing from 30 years of close collaboration with biopharma partners addressing the delivery challenges of complex biologics has led us to the launch of a tailored platform solution: BD Neopak™ Glass Prefillable Syringe.

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and Neopak are trademarks of Becton, Dickinson and Company or its affiliates © 2021 BD. All rights reserved.

BD Vystra™ Disposable Pen is an easy-to-use disposable pen injector for frequent, low-volume injections or variable dosing. The video details BD Vystra™ features and showcases the robust manufacturing process from component assembly through to final packaging for shipment.  

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Vystra are trademarks of Becton, Dickinson and Company © 2021 BD. All rights reserved. 

With more than 2.5 billion glass prefillable syringes processed and sold each year throughout the world, BD has developed and maintained state-of-the-art technology for the manufacture of  Sterile, Clean, ready to Fill syringes. The manufacturing process of BD Glass Prefillable Syringes is implemented in the same way in our plants in France, Hungary, the USA, Mexico and Japan. To meet worldwide demand, we implement worldwide technology processes and equipment through continual investment programs and multi-sourcing. Common Quality Assurance System and worldwide engineering organization guarantee a consistently high quality level, regardless of the manufacturing site. Final conditioning operations such as filling, stoppering, terminal sterilization, labelling and inspection, plunger rod placement and blister packaging are performed at pharmaceutical companies’ or contract-fillers’. 

https://drugdeliverysystems.bd.com/contact-us

Faster, more cost-efficient hospital-based injectable drug delivery - How speed and convenience imperatives in the Covid-19 crisis have challenged the paradigms Overview and a discussion on the evolution of next-generation products Moderator: Yasemin Karanis, Consultant, European Thought Leadership, IQVIA Global Pharma: Trends in Drug Delivery and Formulations -Yasemin Karanis, Consultant, European Thought Leadership, IQVIA The increasing importance of connected devices and digitalization in post-pandemic R&D - Sai Shankar, Vice President, Global Digital Healthcare Systems, Aptar Pharma Illustration of implementing user experience key aspects and outlining holistic integrated combination products support - Mark Tunkel, Director of Business Development, Insight Innovation Center, Nemera Faster, more cost-efficient hospital-based injectable drug delivery - How speed and convenience imperatives in the Covid-19 crisis have challenged the paradigms - Sagar Bejalwar, Global Acute and Specialty Portfolio Leader, BD Medical – Pharmaceutical Systems Trends in sustainable packaging in the FMCG market - how this influences the Pharma business and ongoing developments - Armin Ullmann, Product Manager Sustainable Healthcare Laminates, Huhtamaki Flexible Packaging Sustainable packaging in Merck supply chain – ongoing and future developments - Corinne Ondo, Head of Sourcing Glass & Healthcare Innovation Group Procurement, Merck Healthcare This presentation was originally aired as part of the CPHI Festival of Pharma.

The COVID-19 pandemic has lead governments, companies and research institutions to accelerate vaccine development efforts amid geopolitical crosscurrents. Despite an increased understanding of immune responses to infection, research is often hindered by a lack of knowledge of the immune responses explicitly required for protection, or by a lack of approved adjuvants and delivery systems to induce the needed answers. Licensing new vaccines also require a significant financial commitment which also represents a challenge. This webinar will discuss the hurdles that new vaccines must overcome to reduce morbidity and mortality, as well as some of the initiatives that are being attempted to accelerate and scale up the next generation of vaccine development for global disease prevention. This presentation was originally aired as part of the CPHI Festival of Pharma.

Discover how BD addresses the challenges of IV drug delivery with BD Hylok™️ Glass Prefillable Syringe for IV applications. Learn about its features and performances!

https://drugdeliverysystems.bd.com/contact-us

BD, the BD Logo and BD Hylok are trademarks of Becton, Dickinson and Company © 2020 BD. All rights reserved. 

This webinar originally aired as part of CPHI Discover - 17-28 May 2021 Several factors motivate pharmaceutical companies and hospitals to use glass pre-fillable syringes (PFS) for Intravenous (IV) applications. By switching from vials and ampules to a glass PFS, hospitals have the potential to reduce medical errors, improve workflow efficiency and impact ROI for hospital stakeholders. Moreover, data suggests that approximately 92% of hospital stakeholders are willing to use prefilled syringes for multiple drugs. For pharmaceutical companies, transitioning a fixed-dose drug from its vial or ampule format to a prefilled syringe can serve as a differentiation strategy in a market dominated by vials and ampules. This session will examine the benefits and challenges associated with glass formats and will explore BD’s glass pre-fillable syringe with connection performance verified for IV applications.

This webinar originally aired as part of CPHI Discover - 17-28 May 2021 The need to reduce health care costs, improve outcomes, and increase access to remote care are intensifying the focus on patient care delivery in the home setting. As a result, pharma is seeking alternate delivery systems that can provide patient autonomy and mobility while delivering treatment outside of the clinic. Programmable, variable dose on-body injectors provide such options. This talk will highlight considerations for on-body injectors to promote drug delivery in non-clinical settings.

This webinar originally aired as part of CPHI Discover - 17-28 May 2021 While the initial challenge was in developing effective therapies against COVID-19, the next hurdles are manufacturing at scale, drug delivery solutions, cool chain and logistics. How is the industry responding? COVID Update: The 2021 Vaccine Line Up Facility challenges & production quality control Cold chain challenges Administration solutions-what are the options vs standard injections? Key supply chain challenges for vaccine products Creating sustainable and resilient distribution systems. Challenges in allocating and prioritizing vaccine supplies and distribution

Learnings from preclinical and clinical translational studies using fluoroscopic (preclinical) or ultrasound (clinical) in situ imaging to characterize 0.6-10 mL, 1-50 cP subcutaneous injections delivered by a surrogate pump or an investigational on-body injector Session Outline: Assess the feasibility and/or the tolerability (clinical only) of SC injections up to 10 mL & 50 cP Provide detailed in situ device and depot imagery to reveal what happens beneath the skin surface during drug delivery Explore the relationship between visible tissue effects and underlying depots Qualify and quantify the impact of ambulatory wear on wearable and on-body injector performance and the corresponding tissue effects and subject perception (wearable injector only)

The need to reduce health care costs, improve outcomes, and increase access to remote care are intensifying the focus on patient care delivery in the home setting. As a result, pharma is seeking alternate delivery systems that can provide patient autonomy and mobility while delivering treatment outside of the clinic. Programmable, variable dose on-body injectors provide such options. This talk will highlight considerations for on-body injectors to promote drug delivery in non-clinical settings. This webinar originally aired as part of Pharmapack 2021

High dose biologic formulations are pushing drug volume and viscosity beyond traditional self-injection design space limits (> 15 cP, > 1 ml dose volume), which can challenge patients’ capabilities to administer their injections based on injection time or force. We will discuss how ergonomic, manual, syringe-based injections can enable subcutaneous self-injections with characteristics that go beyond the traditional boundaries of volume and viscosity. Important factors for the development of combination products involving delivery of higher volumes (1-2 mL) are presented, including assembly, human factors, documentation, and platform considerations.This webinar originally aired as part of Pharmapack 2021

BD has teamed up with industry-leading partners in tagging and software technologies to develop a comprehensive solution to deliver traceability at the unique container level. The immediate focus is on pharma manufacturing operations with the goal being to ultimately ensure the integrity of the drug product throughout the supply chain and at the point of consumption. BD would like to assist pharma customers in transitioning their manufacturing lines to unit-level traceability with a coherent path towards end-to-end traceability. This presentation will discuss how interested customers are invited to specify the use case requirements to be built into the traceability solution and test the tagged syringes, production line hardware and software in a pilot project.This webinar originally aired as part of Pharmapack Europe 2021

The devastating global impact of the present pandemic has revealed the challenge of vaccine delivery, and the critical role of packaging and administration material. The 30-minute talk will focus on how prefilled syringes contribute to solve challenges of the vaccine administration. This will include a review of the efficiency gains and waste reduction obtained with the PFS format, with benefits in terms of the workflow efficiency, dose-sparing and waste volume reduction. Finally, drug/container compatibility issues will be explored along with the suitability of PFS technology in meeting the rigours of vaccine cold/frozen chains storage. This webinar originally aired as part of Pharmapack 2021

This session introduces a comprehensive set of services and solutions designed to mitigate the risks associated with combination product development to help you achieve your goals. These services and solutions help you from development all the way through to launch, including container selection, combination product expertise and testing, regulatory and technical documentation support, analytical testing, world-class lab capabilities, ongoing consultation, and more.

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.

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.

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

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.

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 vaccine market continues to grow, vaccine manufacturers are looking to differentiate themselves by seeking solutions for critical challenges that:
Offer end to end vaccine container reliability. Consider cost sensitivity. Support documentation for regulatory scrutiny. Ensure continuity of supply.
BD Effivax™ Glass Prefillable Syringe has been designed in collaboration with leading pharmaceutical companies to meet critical needs such as product integrity, cosmetic quality, and product consistency. It sets new standards of performance that improves end-to-end syringe reliability and can translate into lower total cost of ownership.

An investigational large volume subcutaneous wearable injector delivered 5mL viscous placebo injections to healthy adults with favorable subject tolerability and acceptability. This session outlines:
An investigational large volume subcutaneous wearable injector was evaluated for feasibility of 5mL, ~8cP non-Newtonian placebo injections in abdomen and thigh of 52 healthy adults of two age groups (18-64, 65+ years), with and without movement. Assessment of device performance, tissue effects, depot location and user-reported pain and acceptability.
Benefit: Greater understanding of clinical performance and user perception of this investigational wearable injector may de-risk clinical outcomes as more biotherapies for chronic disease transition from intravenous to subcutaneous administration