Injection devices are becoming more and more important for modern drug delivery in various therapeutic areas. Recent device launches in hypercholesterolemia therapy and for biosimilar products demonstrated the importance of devices to gain and maintain market share in a competitive market.
Benefits for patients are based on reliability and robustness of the drug delivery device and human factor study approved ease-of-use. Reliability in drug delivery is one of the key focus areas for regulatory agencies. They request substantial data sets demonstrating that the whole drug delivery mechanism is under full control by the drug license holder.
Whereas device mechanisms have been developed to a robust and reliable level - the primary packaging material is still in focus as it has not been developed originally for a device driven drug application. Triggered by container issue related product recalls in recent years, regulatory agencies have also realized this fact, and require documenting primary container interface with the device within the filing dossier.
Syringes and cartridges for auto injection systems or pen systems are made typically of glass and require specific handling by the container manufacturer to become "device compatible". Their suitability needs to be proven and confirmed during the whole device qualification process, starting at development and ending at final drug product production. This requires special characterization and handling to ensure integrity of the container is not affected.
This presentation will highlight requirements on containers which need to be fulfilled for successful functionality in injection systems, focusing on auto injectors. It will cover the following areas:
- Critical dimensions of the primary container for a perfect fit with the device
- Performance requirements on the container for issueless combination with drug delivery devices
- Best practices in glass handling during the development process
- RNS versus FNS staked-in needle syringes, advantages and disadvantages
- Glass handling during syringe assembly, learnings from commercialized products
- Assembly line design concepts featuring best practice in glass handling
The importance of glass handling during pharmaceutical manufacturing has become a major interest for regulatory agencies. This webinar will give you insights into best practices in glass handling and guide you through the selection process of a reliable primary container solution.
Prepare for your next drug delivery project by attending our webinar!
Dr. Thomas Schoenknecht,
Executive Director Business Development
Dr. Thomas Schönknecht is currently Executive Director, Business Development at SHL Group, with responsibility for global Business Development, Key Account Management and New Technology Evaluation within SHL’s Medical division.
He has over 20 years’ experience in pharmaceutical industry in various leading roles in project management, research & development and business development. Prior to joining SHL in 2013, Thomas worked at Schott Pharmaceutical Packing Division where he was heading the global Key Account Organization with a specific focus on new product developments addressing customer needs.
Thomas also worked at Amgen Inc California as Director of Drug Product and Device Development, where he oversaw and managed Amgen’s global drug delivery container projects and interfaced Amgen’s drug delivery device platforms.
Prior to being engaged with Amgen he was heading Research & Development activities at Gerresheimer’s Pharmaceutical Packing Division, where he was leading Product Management and Business Development activities for sterile drug delivery solutions.
Thomas has a Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the University of Goettingen, Germany and a Master’s degree in Chemistry from the University of Goettingen. He is a frequent speaker, moderator and committee member at conferences regarding drug delivery and packing material science; Thomas was heading the PDA interest group for prefilled syringes and is currently active as PDA interest group leader for combination products in Europe. In addition he had been active as a member in various DIN ISO committees regarding primary packaging materials and drug delivery devices.
- Selection of suitable primary container for auto injection systems
- Handling requirements for containers during final assembly
- Successful combination of primary container and device
- Packaging
- Device and Packaging Development
- Product Development
- New Product Introduction
- Clinical Supply Chain
- Process Development
- Regulatory
- Business Development
- Device Strategy
- Technical Development
- Commercial Operations
- Research & Development
- Research & Innovation
