• 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
• Regulatory background: MDR (EU) 2017/745 new requirements for drug-devices combination medicinal products and directive 2001/83/EC amendment (article 117 MDR)
• Drug delivery technologies: smart devices, selective, targeted delivery…
• Discussion on implementation issues, impact on device’s technical file and medicines MAA dossier and new challenges and business perspectives for manufacturers
• 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 a 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.
• EU FMD 2019 readiness: have you considered a plan B?
• Learn how to leverage efficiently your serialization data in the supply chain
• Discover how new technologies like Blockchain, Artificial Intelligence and IoT will impact your business for enhanced supply chain security and transparency
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.