• Challenges of aging and the medicalization of society
• What is Inclusive Design and how it relates to pharma packaging
• What previous research says about the use of pharma packaging by patients
• How the pharma industry perceives the challenges to design and innovate in packaging
• Opportunities to address the current challenges in pharma packaging
• Technology and the industry challenge
• The value for stakeholders
• The go-to market
• How success looks
• What steps to consider when going connected OR not
• Breaking down the problem by defining categories of needs for each Stakeholder
• Do you really need a connected device and if so which type?
• Matching solutions to needs to enhance the drug delivery process
• Is it possible to try it out - taking a punt?
• The human factor - just because you make it connected doesn't mean people will use it.
• Overview of the drivers for innovation in smart packaging and connected medical devices
• Current products and processes in the pharma supply chain, current environmental monitoring, packaging etc
• Identification of market failures/opportunities for improvement
• Thought leadership on smart packaging and connected medical devices, how this will provide new solutions and improved outcomes for pharma, the pharma supply chain and patients
• Challenges of managing drug delivery (use steps) from patient and caregiver perspective
• How to identify opportunities to reduce complexity in managing the disease state
• Real world videos documenting patient and caregiver experiences managing treatments for pediatric haemophilia
• Status of Brexit discussions
• Implications for medical device and pharmaceutical companies
• Implications for patients and healthcare professionals
• Practical steps and recommendations
• BEPO(R) technology presentation
• High versatility: key formulation parameters for controlling drug release
• Major advantages versus classical long-acting injectable technologies
• Prospectives in the field of Long Acting formulations of fragile molecules
• ICH Q3D and USP661.1 bring new requirements that could 'shake' the industry if not well prepared
• This regulation destroys the well-worn ‘food contact declarations are enough’
• Packaging supply chain will need to evaluate the impact of the new regulations
• USP661.1 taking full effect in May 2020, you might avoid to be ‘shaken’ into last-minute changes!
Today the standard measure for the chemical durability for parenteral packaging is based on the hydrolytic resistance test (ISO 4802; USP<660>; Ph.Eur 3.2.1) for which the vial is filled for testing to 90% of its brimful volume. However, nowadays an increasing amount of innovative drugs e.g. high-potent drugs will have a low filling volume. Consequently, the determined hydrolytic resistance might not represent the amount of leached glass elements for those volumes. This is attributed to two main contribution factors: One is an increasing ratio of the wetted surface to filled volume. The other contributing effect is an increased leaching tendency typically observed with borosilicate glass of the wetted wall near bottom area (especially when the standard manufacturing technology is applied).
The phenomenon itself will be explained and some analysis data will be presented.
For the Quantification of the contributing effects the amount of the representative leached glass elements boron, sodium and silicon after 24 weeks at 40°C for different fill volumes (0.5, 1.0 and 2 ml) with purified water and 15 % KCl-solution for 2 ml vials made from type I class B borosilicate- and from aluminosilicate glass were investigated.
The commonly established standard conversion process has been applied for both types of glass vials.
• Challenges in the development of parenteral containers for ophthalmic applications / intravitreal injections
• Polymer Syringe with plasma deposited barrier coating and silicone-oil free lubricity coating
• EO sterilization study to show no gas migration into drug product
• Low particles
Conference | Session 3: Sustainability and Pharmaceutical Packaging & Devices: from Threats to Actions
• How EPR legislation is evolving in the EU under the Circular Economy package
• How EPR legislation is evolving around the world
• Changes your business may need to make to adapt to the changes
With public awareness increasing regarding the environmental impact of all the products we use, each market segment is having to review how it designs, develops and specifies its platforms to minimise environmental impact. Medicine packaging and devices are no exception to this and this presentation will review the following:
• What are we doing as an industry to minimise the environmental impact of inhaler devices and packaging?
• What are the threats and opportunities?
• Green Guides and Corporate Social Responsibility reporting
• What next?
• Which biosimilars have been approved?
• Which are available on the market and how are they administered (device/PFS/vial)?
• Litigations or other obstacles preventing launch of approved products
• What lies ahead?
• The importance of consistent bolus formation in the performance of LAIs
• Design considerations when developing an autoinjector for LAI delivery
• The methodologies best used to understand bolus shape and position
• The impact of various delivery parameters on bolus formation
• The market for biosimilars is growing rapidly, creating a vital but challenging need for companies to devise
robust biosimilar defence strategies to maintain their market share
• Simple user experience mapping methods will be demonstrated to show how truly original opportunities to
improve the patient and professionals' experience can be identified
• Technology mapping from these opportunities will then be used to discover how the latest technologies, from digital to
formulation, can provide unique strategic propositions to underpin a compelling biosimilar defence strategy
• Innovation Map revealing emerging application areas in pharmaceutical packaging
• Visualizing Innovation: heatmaps of startup activity, technologies and trends
• Opportunities of working with cutting-edge start-ups
• Alessandro Fato , CTO , Amiko Digital Health Ltd
• Otman Nouri , CEO, Glancy 3D
• Adrien Content, CEO, KOOVEA
• Philippe Rogueda , Founder & Director, Merxin Ltd
• Vincent Barlier, Sales Manager, PragmatIC
Selected by our advisory board, these start-ups will present in this start-up pitching session. Discover what are their strengths, impacts on current market offering and business potential, participate the live Q&A with the advisory board representatives by register for a Conference pass!
Glancy 3D is the first computer vision artificial intelligence for packaging design assessment and optimisation.
The Koovea solution consists of miniaturized, flexible and non-intrusive sensors (Bluetooth/NFC), intelligent LTE routers and our web application.
Merxin provides a new business concept in inhaler development based on popular technologies. Our novelty is about business concept and technology acceleration.
PragmatIC’s unique technology platform opens up the opportunity for low cost, item-level, smart pharmaceutical packaging.
Connected solutions for injection systems have gained momentum the past few years. The generation of health data has become the gold rush of our digital age. More rationally, the digitalization of healthcare is expected to fulfill promises such as increased patient compliance, more impactful patient monitoring for optimal therapy adjustment, confirmation of long-term therapy outcomes and data supporting research to improve medication.
But is connectivity an end in itself and are health data valuable per se?
Herewith we would like to highlight three factors, which we believe are crucial for making a connected injection solution really relevant and useful for a real impact on therapy outcome.
• #1: focus on indication-specific user needs as superior criterion to determine the relevance of connected solutions;
• #2: understand the struggle encountered by patients during their treatment journey to find out how connectivity can solve real problems;
• #3: consider rolling out step by step simple but impactful connected solutions without ambition to solve everything from scratch.
• Considerations for creating a custom primary package
• Challenges with break-through technologies when bringing to scale.
• Regulatory considerations
• Elements of a successful partnership
While new concepts emerge regularly and can provide break-through results in small batches, leapfrog technologies can be difficult to scale. One root cause to this challenge is the need to fit within legacy systems - especially in manufacturing lines that are expensive to change. Thus can be the challenge with drug delivery - how to develop a new delivery solution that won’t require a pharmaceutical firm to change their manufacturing line - a costly and lengthy process.
Portal’s needle-free injector utilizes a custom primary container (cartridge) with a patented nozzle to contain the pharmaceutical product within the injector device. Portal realized that to achieve speed and efficiency to market they would have to work within the constraints of existing, standard fill lines. The cartridge that Portal needs has several challenging requirements: being compatible with existing standard pharmaceutical product fill lines, use approved materials for biological drugs and achieve extremely tight tolerances for the super-fine needle-free jet injection.
• Range of product failures due to packaging on manufacturer
• Case studies demonstrating improvements with upgraded packaging
• Economic impact of upgraded packaging
Challenges and quality expectations for delivery of injectable drugs are rapidly evolving driven by patient communities, regulatory bodies, health care providers, drug manufacturers and drug developers. Failures of packaging components can have a significant impact on one or all of these communities and that cost can have a far more detrimental impact on manufacturers than the initial cost of upgrading a packaging component.
Furthermore, ensuring reliability of the container closure system becomes even more complex as fill finish processes operate at increasingly higher speeds with increasing levels of automation.
In this talk, we will review the impact of high-performance packaging components from the various viewpoints of the patient, the health professional, and the drug m
• From Big Data to Smart Data: the new challenges at line, plant and corporate level in a serialized world
• Intelligent Thinking: how serialization can provide data-driven actions to improve production and warehouse operations
• Industry 4.0 and the benefits of an comprehensive approach to guarantee the quality, integrity and traceability of medicines, containers and packaging
Corporate scandals such as counterfeiting, contamination and cheap labor exploitation impact patients’ safety in the healthcare and the food and beverage industry, and change consumer behavior across the globe.
Discover the vital role of end-to-end traceability in making a better and intelligent supply chain, from the extraction of raw materials, all the way up to the end user and disposal. Leverage cutting-edge technologies to deliver supply chain security, global visibility and brand protection.
Provide a safe product to guarantee its authenticity, to facilitate return and recall management while creating efficient manufacturing processes. Improve your performance, build lasting and trusting relationships with suppliers and clients, and ensure a more sustainable future thanks to end-to-end traceability.
With this presentation, the audience will understand how end-to-end traceability can help companies gain visibility among their supply chain, increase their performance, improve the safety of their products and ultimately of their customers.
• Overview about the NTIN/GTIN codifications situation in Europe. Is it possible to make multi-market productions?
• What’s the impact of this heterogeneous regulation landscape on the serialization systems ? Are the consequences different for a Level 2-3 solution vs a Level 4 solution ?
• Will it make the process of Serialization IT system validation and qualification more difficult ? Can the necessary/mandatory updates be managed in a smooth way or does this on-going process have business outcome ?
Omplementation of an innovative high-speed laser-marking solution on glass prefilled syringes at Sanofi Pasteur. This track and trace solution applies to all types of glass syringes and has the primary objective to drastically enhance mix-up prevention.
Through the case study, the audience will understand how a pharmaceutical company is tackling significant issues such as traceability, container identification and manufacturing flexibility through the implementation of an innovative marking technology.
The audience will get an overview of the key criteria defined by Sanofi Pasteur to select this technology. The audience will also understand how this implementation can be done on high-speed industrial processes through description of the project and the main challenges.
The audience may also better understand the additional benefits this technology could bring such as anti-counterfeiting and supply chain flexibility.
Hybrid systems are electronic devices where traditional silicon integrated circuits are embedded within functional smart substrates comprising flexible batteries, sensors, interconnects, antennae and displays and represent the only viable solution to integrate sophisticated functionalities in miniaturized systems in a cost-effective way. Such systems are the natural endpoint of the rush to ubiquitous computing and while still in their early days, are ultimately aimed to be deployed in a number of industries from logistics to medical devices, from consumer electronics to industrial sensing in mass volumes (hundreds of millions to billions per year) and usually have ultra-low target prices (few tens of cents).
The design and development of these tiny but complex devices poses tight constraints from system design to process development, and from materials selection to assembly equipment design.
In this work we present the unique challenges presented in the development of a new generation of flexible hybrid electronic devices and the critical role of such systems to unlock new applications for disposable.
• From the perspective of a polymer based component and device manufacturer
• On the examples of silicone based micro and 2-component parts for smart, wearable combination products to implantable
drug eluting devices
• Shoulder-to-shoulder development between drug, device and components
• From concept to serial production via scalable process development
• Design for Manufacture (DFM) and process integrated quality
In partnership with Voisin Consulting Life Sciences.
• Drug delivery technologies: smart devices, selective, targeted delivery…
• Regulatory background: MDR (EU) 2017/745 new requirements for drug delivery devices and drug-devices combination medicinal products and directive 2001/83/EC amendment (scrutiny and clinical evaluation, article 117)
• Discussion on implementation issues, impact on device’s technical file and medicines MAA dossier and new challenges and business perspectives for manufacturers
Drug delivery devices are becoming increasingly complex and integrated, combining various advanced technologies (digital, coated, nanoparticles…) allowing to deliver the right dose at the right time and right location. They can be ruled as medical devices on their own, as well as device’s part of drug-device combination products regulated as medicinal products. We will explain in practical terms the regulatory requirements of the Medical Device Regulation (EU) 2017/745 (MDR) for these products (including for their digital components), with a focus on the clinical evaluation scrutiny by an expert panel prior to the placing on the market and on the article 117 which clarifies that the medical device constituent part of a medicinal product shall comply with MDR general safety and performance requirements. Finally, we will discuss the new business challenges and operational model implied by this regulation for pharma and medtech industries.
• China FDA regulatory update on drug packaging & drug delivery devices and the impacts for new drug registration
• Expectations and suppliers management from Chinese pharma companies perspective
• Business opportunities and advices for China market entry
• Shelf-life - Up to 200% longer shelf-life compared to previous solution
• Safety in application - Pre-filled accurate dose, controlled droplet size during spraying, no dripping before and after application
• Handling - Easy, intuitive handling allows healthcare professionals to focus fully on the patient
• Hygiene - Traceable single use device enhances infection control
• Comparison of the three irradiation technologies
• Quality and technical advantages of irradiation with regards to product feasibility
• Case studies
• Increased authorities’ attention towards caps as part of a vial closure system to protect the drug content
• Trend to bring secondary packaging closer to or into cleanroom environments
• Technological development at machine manufacturers require more performant closures
• Multilayer Plastic Vial and Syringe
• Excellent oxygen and UV barrier to prevent oxidation of drugs
• Very low extractables
• Customizable vial and syringe
• Advantages of Drug Repurposing
• Overcoming Challenges
• Successful Transitions
• Regulatory Perspective
• What is the Digital Medicines Eco-system
• Impact on patient health outcomes and the overall healthcare system
• How to build a successful eco-system
• Stakeholder’s perspective
• Elastomeric components are the major contributor to leachables in the drug product
• A migration study was performed to evaluate potential leachables from both steam and gamma irradiated Ready to Use (RTU) and ETFE coated injectable components
• The results from this study, which demonstrated comparability in leachable profiles, will be present
• Assessing user needs in Hyaluronic Acid delivery
• Addressing user needs through an optimal Hyaluronic Acid delivery system
• BD Hylok™: designed to enhance user experience in Hyaluronic Acid delivery
• Speed of innovation • Drug Delivery Devices in a broader smart ecosystem: From Diagnosis to AI
• Which benefits for the patients, pharma, and payers?
• Go to market and business models
Developing and bringing a biological drug to market is very expensive and involves risks in every stage of the project. Primary packaging is an integral part of the drug and selecting the right packaging components is crucial for the success of the project. Drug developers and manufacturers who do not understand the full impact of primary packaging on their drug product are taking a significant risk in terms of product stability, patient safety and regulatory scrutiny. The new biological drugs also demand innovative primary packaging solutions.
Learn about the next generation of packaging solutions for biological drugs to avoid the common pitfalls and put your biological drug on a “fast track” to success.
• 1-3 days deliverytime for secondary packaging
• No minimum/No maximum quantity
• Near-site/On-site production
• Lower cost per box
• An innovative answer to cGMP Annex 1 requirements on vial sealing
• Improving process efficiency by suppressing vial crimping
• Creating an integrated ecosystem to enhance adoption of RayDyLyo
• Ready to Use packaging components: Market evolution
• Moulded Glass Vials RTU: why do we need them?
• The strengths of moulded and especially with new products
• Value Proposition of SGD Pharma Sterinity Platform
• How artificial intelligence helps to optimize respiratory therapies by improving adherence and inhaler technique
• How to make medical information clear and improve patient engagement with connectivity and digital solutions
• Importance of compliance for treatment efficacy
• Innovative devices for nasal delivery: Advancia, new generation pump platform
• Correlating enhanced compliance and patient experience
• How QbD process differs from traditional process in terms of focus, approach, and quality assurance
• How QbD process is needed in order to meet demands of advances in: biologic and complex small-molecule drug products, high-value treatments, stricter regulations, and self-administration systems
• How QbD process can be applied to design and manufacture of plungers, resulting not only in plungers of higher quality, but better performance.
• Overview of VH2O2 low temperature terminal sterilization process and applications
• How to approach process validation in low temperature terminal sterilization applications
• Overview of VH2O2 low temperature material transfer decontamination applications
• How to approach validation of atmospheric VH2O2 material transfer chambers
• System integration of a prefillable syringe in an autoinjector
• Safe and effective drug delivery to patients
• Benefits of system integration and lessons learned after 8 years of BD Physioject™ commercialization
Packaging quality control is a delicate process, especially in pharma where regulatory bodies rule and customer safety comes first. Automation is proven to dramatically decrease the likelihood of text mistakes in regulatory submissions, inconsistencies in digital artwork files early in the revision process, and print defects/ typos on the printed samples before going to market. Recalls may still be a reality in this day and age, but so are tools that protect against them.